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Clinical Guidelines

PROMOTING EXCELLENCE IN TRANSFUSION MEDICINE

Guidelines for Massive Transfusion In Nova Scotia

November 2010

CONTENTS Document Development............................................................................................................2 Acknowledgements ...................................................................................................................3 Introduction...............................................................................................................................5 Guideline....................................................................................................................................6 4.1 Definitions................................................................................................................……6 4.2 Therapeutic goals .............................................................................................................7 4.3 Selection of blood component therapy ...........................................................................7 4.3.1 Red Cells................................................................................................................7 4.3.2 Platelets ..................................................................................................................7 4.3.3 Fresh Frozen Plasma/Frozen Plasma (FFP/FP) and Cryoprecipitate.....................7 4.4 Communication.................................................................................................................8 5. Massive Transfusion Algorithm ..............................................................................................9 5.1 Explanation of Algorithm ...................................................................................................... 11 6. References................................................................................................................................14 1. 2. 3. 4.

Appendix A Selected C.S.A. Z902-10 Standards Pertinent to Massive Transfusion ...................17 Appendix B Conflict of Interest Declaration for Massive Transfusion Working Group..............20 Appendix C Nova Scotia Framework for recombinant Factor VIIa (Niastase®) Utilization in the Massive Bleeding Patient...............................................................................................................22

Toolkit for Massive Transfusion in Nova Scotia
1. Preprinted Physician’s Order Template for Massive Transfusion ….….…...………….31 (Facilities with platelet inventory) 2. Preprinted Physician’s Order Template for Massive Transfusion…………………...…33 (Facilities without platelet inventory) 3. Preprinted Physician’s Order Template for rFVIIa for Massive Bleeding……………...35 (Compassionate Release) 4. Massive Transfuion/rFVIIa/octaplex Utilization Data Collection Tool User’s Guide.....37 5. Massive Transfuion/rFVIIa/octaplex Utilization Data Collection Tool.……………..…..50 6. NSPBCP Utilization Discard Form (rFVIIa/octaplex®)……………………………….….51 7. Massive Transfusion Standard Operating Procedure…………………………………….52 8. Massive Transfusion Protocol Log Form…….…………………………………………....60

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1 Document Development
This summary of guidelines and information on Massive Transfusion has been prepared specifically for use in Nova Scotia. The information in this document is intended as suggested guidelines, procedures, and forms to provide clinical guidance to healthcare professionals on the use of blood and blood components during the management of massive blood loss. The Nova Scotia guideline has been developed by a multi-disciplinary working group representative of medical experts and health care professionals from both adult and pediatric facilities throughout the province of Nova Scotia. Membership included representatives from hematology, anesthesiology, emergency medicine, critical care, nursing, medical laboratory technology, transfusion medicine, Canadian Blood Services, Perioperative Blood Conservation Program and the Trauma Program. Peer reviews and clinical recommendations were also obtained from interventional radiology and obstetrics and gynecology to ensure applicability of these guidelines as well as consumer review. The development working group was convened by the NSPBCP. Recommendations are based on appraisal of relevant literature and consensus of the working group. As recombinant Factor VIIa (Niastase®) is included in the Massive Transfusion Algorithm, the Nova Scotia Framework for recombinant Factor VIIa (Niastase®) Utilization in the Massive Bleeding Patient has been provided as Appendix C. A toolkit for Massive Transfusion in Nova Scotia has also been provided to support the implementation of the Massive Transfusion Guideline as well as to support the evaluation of the guideline. The toolkit provides pre-printed order forms, data collection tools, laboratory standard operating procedure, discard and log forms.

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Acknowledgements

The following Guideline for Massive Transfusion in Nova Scotia has been prepared in collaboration with the Provincial Massive Transfusion Working Group (PMTWG). The Nova Scotia Provincial Blood Coordinating Program (NSPBCP) would like to acknowledge its appreciation for the tremendous and diligent work of the provincial working group, which provided invaluable contributions in the development of this guideline. The PMTWG acknowledges the British Committee for Standards in Hematology; Guidelines on the Management of Massive Blood Loss (2006) which has been adopted and adapted as a framework for the Nova Scotia guideline. Provincial Massive Transfusion Working Group: Dr. Dorothy Barnard
Division Head Immunohematology, IWK Health Centre Halifax, NS

Dr. Natalie Yanchar
Medical Director IWK Trauma Care Halifax, NS

Dr. Robert Green
Department of Emergency Medicine QEII Health Sciences Centre Halifax, NS

Richard Crouse
Medical Laboratory Technologist South Shore Health Bridgewater, NS

Dr. Eiad Kahwash
Medical Director, Canadian Blood Services, Nova Scotia and Prince Edward Island

Cheryl Doncaster/Michael Jackman / Colin Power
Hospital Customer Service Representative, Canadian Blood Services, NS/NL Halifax, NS

Dr. Blaine Kent
Chief, Division of Cardiac Anesthesia QEII Health Sciences Centre. Surgical Director, Perioperative Blood Management Program Halifax, NS

Derek LeBlanc/ Dawnelda Murray
Program Manager, Emergency Health Services Nova Scotia Trauma Program Halifax, NS

Heather Mingo
Conservation Nurse Coordinator Perioperative Blood Management Program Halifax, NS

Dr. Samuel Minor
General Surgery Critical Care Medicine Halifax, Nova Scotia

Michelle Rogerson
Regional Manager Production CBS, NS/PEI

Dr. Irene Sadek
Medical Director, Blood Transfusion Services, Capital District Health Authority Halifax, NS

Ruth Woodacre
Orientation/Education Pictou County Health Authority New Glasgow, NS

Dr. Romesh Shukla
Chief of Women’s and Obstetric Anesthesia IWK Health Centre Halifax, NS

NSPBCP Dr. David Anderson
NSPBCP Clinical Advisor

Dr. John Tallon
Medical Director of Trauma Nova Scotia Trauma Program Halifax, NS

Marina Hamilton
NSPBCP Manager

Susan Cairns
NSPBCP Utilization Transfusion Practice Coordinator

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Peer Review and Consultations were obtained from: Dr. Robert J. Abraham
Diagnostic Imaging QEII Health Sciences Centre Halifax, NS

Dr. David Young
Obstetrics and Gynecology IWK Health Centre Halifax, NS

Dr. Eileen McBride
Division Head Immunohematology, IWK Health Centre Halifax, NS

Declaration of Conflict of Interest All members of the Provincial Massive Transfusion Working Group completed the Conflict of Interest form with one member reporting they have previously conducted research for and presently hold stock in the manufacturing company for activated recombinant Factor VII (rFVIIa), Novo Nordisk Inc.

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Introduction

The Nova Scotia Provincial Blood Coordinating Program (NSPBCP) is a provincial program of the Acute and Tertiary Care Branch of the Nova Scotia Department of Health. The NSPBCP was created in January 2003 and provides leadership in promoting excellence in transfusion medicine. The NSPBCP collaborates with health care providers in the DHAs/IWK and Canadian Blood Services (CBS) in order to support the appropriate management and safe administration of blood and blood products to patients in Nova Scotia. As a Provincial Program, the strategic directions of the NSPBCP are determined by a Program Advisory Council, while working groups advise and support the NSPBCP in the development of blood related standards. During the development of the Nova Scotia Provincial Blood Contingency Plan, the working group identified the need for a massive transfusion guideline in order to provide guidance and standardization for the use of blood and blood components in patients who are massively bleeding. Recent literature supports a more aggressive use of plasma with or without platelets for patient requiring massive transfusion. This literature was considered in the development of the guideline. A study by Dr. A. Sauaia et al (1995) found that “hemorrhagic shock is the second most frequent cause of death in trauma patients and is the leading cause of early in hospital trauma deaths” (as cited in Tien, Nascimento Jr, Callum and Rizoli, 2007, p.202). In adults, the mortality following massive hemorrhage is greater than 50% (Shaz, Dente, Harris, MacLeod and Hillyer, 2009, p. 1760). “Implementation of a Massive Transfusion Protocol (MTP) promotes early and aggressive coagulation factor therapy as well as the limitation of crystalloid infusion, the prevention of coagulopathy, hypothermia and acidosis” (the ‘Lethal Triad’), and permission for moderate hypotension (Shaz et al, 2009, p. 1766).

Figure 1: The interplay between metabolic acidosis, hypothermia and progressive coagulopathy in trauma (modified from Moore & Thomas Memorial lecture, with permission from Excerpta Medica Inc.) (as cited in Spahn & Rossaint, 2005, p.133)

“The transfusion and coagulation management in children with traumatic injuries is largely unknown. The optimal MTP in children may differ from that for adults, as trauma-induced coagulopathy and MTPs are largely unstudied in the pediatric population” (Shaz et al, 2009, p. 1766).

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Guideline

The objective of the guideline is to provide clinical guidance to healthcare professionals on the use of blood and blood components during the management of massive blood loss. Guidelines should not replace specific decisions for individual patients, and do not substitute for the shared decisions between any patient and doctor (or other health professional) which are unique to each circumstance. Guidelines provide evidence-based background information and consensus-based recommendations for consideration when making individual decisions. 4.1 Definitions Mollison et al (1997) defined massive blood loss as “the loss of one blood volume or more within a 24 hour period, (as cited in Stainsby, MacLennan, Thomas, Isaac, Hamilton, 2006, p. 634) the “normal adult blood volume being approximately 7% of ideal body weight in adults and 8-9% in children” (Stainsby, MacLennan, Hamilton, 2000, p. 487). Fakhry & Sheldon (1994) gave “alternative definitions that may be more helpful in the acute situation include a 50% blood volume loss within 3 hours or a rate of loss of 150 ml/min” (as cited in Stainsby et al, 2006, p. 634) or requiring four (4) units (or 40 mL/kg in children) of RBCs in four (4) hours in the setting of major bleeding.

Table 1: Classification of hemorrhage in the adult Blood Loss (mL) Blood Loss Pulse rate Blood Pressure Pulse Pressure (mm Hg) Respiratory Rate Urine Output (mL/hr) Capillary refill Extremities (color) Complexion CNS/ Mental status Class I Up to 750 Up to 15% Less than 100 Normal Normal or Increased 14 - 20 Greater than 30 Normal Normal Normal Slightly Anxious Alert None Class II 750 - 1500 15% - 30% 100 - 120 Normal Decreased 20 - 30 20 - 30 Slow (>2 sec) Pale Pale Mildly Anxious or Aggression Class III 1500 - 2000 30% - 40% 120 - 140 Decreased Decreased Class IV Greater than 2000 Greater than 40% Greater than 140 Decreased Decreased Greater than 35 Negligible Undetectable Pale + cold Ashen Confused, lethargic, unconscious Blood + crystalloid

Fluid Replacement

30 - 40 5 - 15 Slow (>2 sec) Pale Pale Anxious, confused, aggressive / drowsy Crystalloid/colloid Blood + crystalloid

Note. Adapted from British Committee for Standards in Haematology Blood Transfusion Taskforce (BTT) 2001 and American College of Surgeons (ACS), 2008

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4.2 Therapeutic goals “It is imperative to recognize major blood loss early and institute effective action promptly if shock and its consequences are to be prevented” (Stainsby et al, 2006, p. 634). Sauaia et al (1995) found “coagulopathy is present in 65% of patients requiring massive transfusion and hemorrhage may account for 33% of in-hospital deaths, particularly in the first 24 hours” (as cited in Shaz et al, 2009, p. 1760). Hewson et al (1985) and Ferrara et al (1990) stated “coagulopathy after hemorrhage is thought to be a secondary event because of the triad of depletion and dilution of coagulation factors, acidosis, and hypothermia” (as cited in Shaz et al, 2009, p. 1760) associated with massive transfusion. Iserson and Heustis (1991) have stated that “hypothermia increases risk of end organ failure and coagulopathy” (as cited in Stainsby et al, 2006, p. 636) and may be prevented by pre-warming of all resuscitation fluids, external warming devices such as warm air blankets, thermal caps, heated respiratory gases and the use of temperature controlled blood warmers. (ACS, 2008, p. 67) 4.3 Selection of blood component therapy 4.3.1 Red Cells Hemoglobin and hematocrit levels should be monitored, although the hemoglobin level may be a poor indicator of blood loss in the acute situation. Red cells are rarely indicated when the hemoglobin concentration is greater than 100 g/L but almost always indicated when it is less than 70 g/L. (British Committee for Standards in Haematology Blood Transfusion Taskforce, 2001) Schwab et al (1986) advise it is acceptable to give group O Rh (D) positive RBCs to females of non-childbearing potential and to males with unknown blood group (as cited in Stainsby et al, 2006, p. 637). Children and women with childbearing potential should receive Group O Rh (D) negative RBCs (CSA Standard Z902-10, page 56). Group specific RBCs or compatible RBCs (if group specific are not available) should be given as soon as possible. 4.3.2 Platelets Platelets should be transfused when the count falls below 75 x 109/L in the acutely bleeding patient or below 100 x 109/L in patients who have sustained a CNS injury (ACS, 2008) or for those with multiple high-velocity trauma (Stainsby et al, 2006, p. 638). Group specific platelets or compatible platelets (if group specific are not available) should be given as soon as possible. If Rh positive platelets are given to a female with childbearing potential and the patient is later determined to be Rh negative, consider passive immunization with an anti-D agent such as WinRho®. For the purpose of massive transfusion, 1 adult dose of platelets = one buffy coat unit of platelets = 4 random donor platelets = one unit of apheresed platelets. 4.3.3 Fresh Frozen Plasma/Frozen Plasma (FFP/FP) and Cryoprecipitate It is essential that laboratory tests for coagulation (PT/INR, PTT and fibrinogen) be monitored frequently and may require interpretation by a hematologist.
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“Plasma is less inflammatory than artificial colloid, albumin or lactated ringers” (University Health Network, Ont.) therefore plasma should be initiated as soon as possible. Early and intensive therapy with plasma and platelets appear to be associated with better patient outcomes. (McClelland, 2007) “For trauma patients presenting with exsanguinating hemorrhage, coagulopathy correction beginning with aggressive FFP administration may improve resuscitation and outcome” (Gonzalez et al, 2007, p. 119). “FFP/FP alone, if given in sufficient quantity, will correct fibrinogen and most coagulation factor deficiencies, but large volumes may be required” (Stainsby et al, 2006, p. 638) because of rapid consumption. Hippala (1998) advised “if fibrinogen levels remain critically low (less than 1.0 g/L), cryoprecipitate therapy should be considered” (as cited in Stainsby et al, 2006, p. 638). Group specific FFP/FP or compatible FFP/FP (if group specific are not available) should be given as soon as possible. Table 2: ABO Compatibility for RBCs, Plasma, and Platelets
Recipient ABO Group UNKNOWN O A B AB RBCs O O A,O B, O AB, A, B, O Donor ABO Group Plasma AB O, A, B, AB A, AB B, AB AB Platelets AB O, A, B, AB A, AB B, AB AB

Note. Adapted from Canadian Blood Services (2007). Clinical Guide to Transfusion.

4.4 Communication Treating clinicians will determine when to transfer patients based on the medical needs of the patient and the resources/capabilities of the sending institution or patient care unit. Inpatients Transfers of massively bleeding inpatients should be facilitated through existing routine transfer processes. Trauma Patients Transfers of trauma patients should be facilitated through The Nova Scotia Trauma Program. The Provincial Trauma Team Leader can be contacted at 1-800-743-1334, if inter-facility transport is being considered. Initiation and Termination of MTP To minimize miscommunication, the physician leading the resuscitation efforts or delegate should initiate and terminate the MTP with the blood bank. Similarly, within the blood bank each MTP should be coordinated by a single blood bank technologist.

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Massive Transfusion Algorithm

The recommendations have been summarized in algorithm format and should be displayed in high-risk clinical areas, e.g. emergency departments, intensive care units, operating rooms, labor/delivery/recovery unit and blood transfusion laboratories. Massive transfusion is clearly defined as are the goals of treatment. The algorithm also provides clear description of key steps of treatment. Documentation should consist of a minimum dataset that must record: type of blood component or replacement fluid, time given, amount (dosage), indication for replacement, effectiveness of the transfusion. Full traceability of blood components transfused is imperative. Accurate documentation of blood components given, reason for transfusion and any adverse reactions observed, is necessary in order to enable audit of outcome and satisfy compliance with standards for full traceability (CSA Standard Z902-10).

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MASSIVE TRANSFUSION ALGORITHM
MEDICAL-SURGICAL INTERVENTIONS • Prior to initiation of treatment, send STAT: CBC, INR/PTT, Fibrinogen, Electrolytes, Creatinine, Ionized Ca++, Mg++, serum lactate, Group and Screen, Blood Gas (blood work done based on facility’s capabilities) • Consider cell salvage • Warm all fluids • Perform appropriate surgical/interventional radiology interventions in order to control bleeding • Anticoagulant reversal • Oral anticoagulants (e.g. Coumadin®) Octaplex® 40 mL IV AND Vitamin K 10 mg IV • Heparin-Protamine 1 mg for every 100 U Heparin IV INITIAL TRANSFUSION MANAGEMENT: Adults: RBCs 6 units, Plasma 1500 mL and Platelets* 1 unit Pediatrics: RBC 15 mL/kg and, Plasma 10-15 mL/kg and Platelets* 5-10 mL/kg * In hospitals where platelets are not inventoried, if the patient will be managed on site, consider requesting platelets from CBS. CONSIDER DISCONTINUING BLOOD COMPONENT THERAPY WHEN • Shock has resolved and bleeding is under control Inform BTS upon termination of the MTP

IDENTIFY AND TREAT ACTIVE BLEEDING (Obstetrical, Surgical, Trauma, Medical)

STABILIZE AND TRANSPORT TO REFERRAL CENTRE Care should be initiated within the resources and capabilities of the sending institution, which will vary depending upon the hospital.

REASSESS • CBC, INR/PTT, fibrinogen, Blood chemistries as appropriate

FOR ONGOING BLEEDING Repeat blood components based on lab results and in consultation with BTS. ACTIVATE MTP if patient is bleeding with anticipation of ongoing blood loss or bleeding requiring at least four (4) units of RBCs (adults) or 40 mL/kg (children) in four (4) hours. • Establish or assign patient identification CALL BLOOD TRANSFUSION SERVICE (BTS) TO ACTIVATE MTP • Provide contact information of physician leading the MTP • Provide patient information • BTS will notify the BTS Medical Director as appropriate MAINTAIN: Ionized calcium greater than 1.13 mmol/L Urine output greater than 0.5 mL/kg/h Systolic blood pressure greater than 70 mmHg Temperature greater than 35ºC pH greater than 7.10 Consider: MAINTAIN: Hemoglobin above 70 g/L with: RBCs - Adults: 2-10 units Pediatrics: 15 mL/kg Platelets above 75 x 10 9 /L OR above 100 x 10 9 /L (CNS injury) with: Platelets - Adults: 1 unit Pediatrics: 5-10 mL/kg INR below 1.7 with: Plasma- Adults: 500-1500 mL Pediatrics: 10-15 mL/kg Fibrinogen above 1.0 g/L with: Cryoprecipitate-Adults: 10 units Pediatrics: 1 unit/10 kg
www.gov.ns.ca/health/nspbcp/

Antifibrinolytics Tranexamic acid – 10 mg/kg IV Other Prohemostatic Drugs DDAVP – (max 20 mcg) Adults: 10.0 mcg/m2 IV Pediatrics: 0.3 mcg/kg IV Recombinant Factor VIIa 0.020-0.050 mg/kg IV Direct

PrinA1109_12_10

NSPBCP Guideline for Massive Transfusion in Nova Scotia November 2010

4.1 Explanation of Algorithm Identify and treat active bleeding (Medical, Obstetrical, Surgical, and Trauma). Stabilize patient and transport to referral centre. Care should be initiated within the resources and capabilities of the sending institution, which will vary depending upon the hospital. Activate the Massive Transfusion Protocol (MTP) - Criteria for activation of the Massive Transfusion Protocol: Bleeding with the anticipation of ongoing blood loss or requiring at least four (4) units of RBCs (adults) or 40 mL per kg (children) in 4 hours. o Emergency Health Services may activate the Massive Transfusion Protocol (MTP) prior to arrival to an emergency department. o Call Blood Transfusion Service (BTS) Provide the name, location and phone number for the physician leading the MTP Patient name, age, sex, HCN, diagnosis, any known special transfusion requirements (e.g., antigen negative, CMV-negative or irradiated), treatment to date. If patient name and/or health card number (HCN) are unknown (e.g., patient not yet registered in the hospital), request that a unique anonymous identifier be provided. “All patients must be identified by two independent and unique alphanumeric identifiers” (American Association of Blood Banks, 2005, p. 7). Request immediate issue of uncrossmatched blood components. The initial MT package for adults with an unknown blood group should contain six units of RBCs, 1500 mL FFP/FP and 1 adult dose of platelets. Upon confirmation of the patient’s blood grouping, the blood bank should issue group specific or compatible RBCs, FFP/FP and platelets. For children under 50 kg, the transfusion amounts are FFP/FP = 10-15 mL/kg and RBC = 15 mL/kg and platelets = 5-10 mL/kg. Note: a patient sample must be collected even if uncrossmatched RBCs have been requested. BTS to notify their Medical Director of the activation of the MTP as appropriate. Medical-Surgical Interventions: o Perform the following laboratory investigations prior to initiating any fluid resuscitation: Draw a group and screen as per normal sample collection policy, CBC, aPTT, INR, fibrinogen, arterial blood gas, electrolytes, serum creatinine, ionized Ca++, as per facility capabilities. The pre-transfusion testing may be abbreviated according to policies and procedures established by the medical director. (CSA Standard Z902-10, p. 56) o Ensure adequate venous access with two large bore IV lines. o Initiate fluid resuscitation with either normal saline or Ringer’s lactate, start FFP/FP infusion as soon as available. Permissive hypotension (e.g. systolic BP no higher than 90 mmHg) should be considered, particularly for penetrating torso trauma. (Tien et al, 2007, p. 205)

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o Infuse all fluids including RBCs, plasma and crystalloid via a rapid infuser with inline warmer. Infuse Group O RBCs (Rh negative to children and women of childbearing age). For infants under 4 months of age, “only RBCs that are negative for hemoglobin S should be transfused.” (CSA Standard Z902-10, p. 56) o “Employ cell salvage if available. If blood loss is from a clean surgical field in a patient without underlying malignancy, initiate cell salvage procedures where available.” (Capital Health, 2010) o RBCs, platelets, Fresh Frozen Plasma/Frozen Plasma (FFP/FP), and cryoprecipitate must be infused as per hospital policy. o Perform all appropriate surgical and interventional radiology interventions in order to control bleeding. o Ensure all required relevant services are notified, including surgery, interventional radiology, anesthesia and critical care. o Discontinue all anticoagulants and consider specific antidotes as follows:
Table 3: Anticoagulants and Antidotes Anticoagulant Unfractionated heparin (UFH) Low molecular weight heparin (LMWH) or heparinoids Examples Heparin Dalteparin, Enoxaparin, Danaparoid Antidote Protamine sulfate 1 mg/100 U Unfractionated Heparin Vitamin K 10 mg. IV AND prothrombin complex concentrate (octaplex®) 40 mL. No specific antidote No specific antidote Platelet transfusion

Vitamin K antagonists

Warfarin® (Coumarin), Sintrom® (Acenocoumarol)

Direct thrombin inhibitors Pentasaccharides Antiplatelet agents

Lepirudin, Bivalrudin, Argatroban, Dabigatrin (Pradax) Fondaparinux, Idraparinux ASA, NSAIDs, Clopidogrel, GP IIb/IIIa inhibitors

Note. Dose of antidote may be reduced if anticoagulant has already been held several hours earlier. Hematology consultation recommended. Note. Adapted from University Health Network, Policy & Procedure Manual. Massive Transfusion Protocol-Clinical.

Initial transfusion management o Adults - 6 units RBCs, 1500 mL FFP/FP, 1 adult dose of platelets o Pediatrics – 10-15 mL/kg RBCs, 10-15 mL/kg FFP/FP, 5-10 mL/kg platelets o In hospitals where platelets are not inventoried, if the patient will be managed on site, consider requesting platelets from CBS. o Women with child bearing potential and children should receive Rh negative blood components. o Reassess bleeding rate between doses of blood products. Repeat CBC, INR/PTT, fibrinogen and blood chemistries as appropriate (serum lactate q4hours). Document transfusions and relevant laboratory tests. o For ongoing massive bleeding, order blood products based on the last available laboratory tests.
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For ongoing bleeding o Reassess for source of active bleeding. o Consider: • activated Recombinant Factor VIIa = 0.020 – 0.050 mg/kg (Moltzan et al, 2008, p. 118) Note: rFVIIa should only be considered “as an adjunct to surgical control of hemorrhage in patients with massive bleeding, after 8 units of RBCs have been transfused and if there is still evidence of marked, ongoing bleeding.” (Tien et al, 2007, p. 208) • DDAVP = Maximum 20 mcg. Adults – 10 mcg/m2 Pediatrics – 0.3 mcg/kg • Tranexamic Acid = 10 mg/kg intravenously o Goals of Treatment Maintain: • ionized calcium greater than 1.13 mmol/L • urine output greater than 0.5 mL per kg/h • systolic blood pressure greater than 70 mmHg • temperature greater than 35oC • pH > 7.10 o Transfusion Guidelines

Table 4: Transfusion guideline based on laboratory results Laboratory Results
Hemoglobin less than 70 g/L Hemoglobin less than 100 g/L for patients with cardiac disease

Product and Dose

Adults - 2-10 units RBCs Pediatrics - 15 mL/kg RBCs Adults - 1 adult dose of platelets 9 9 a Platelet less than 75 x 10 /L OR 100 x 10 /L CNS injury Pediatrics - 5-10 mL/kg Adults - 500-1500 mL FFP/FP INR greater than 1.7 Pediatrics - 10-15 mL/kg FFP/FP Adults - 10 units cryoprecipitate Fibrinogen less than 1.0 g per liter Pediatrics - 1 unit cryoprecipitate per 10 kg a Do not rely on platelet count within 12 hours of cardiopulmonary bypass or within 24 hours ingestion of antiplatelet agent; administer maximum of 2 doses of platelets empirically. Note. Adapted from University Health Network, Policy & Procedure Manual. Massive Transfusion Protocol-Clinical and CBS, 2007.

Consider discontinuing blood component therapy when: o there is resolution of shock and bleeding is under control Inform blood transfusion service when control of bleeding has been regained, or when resuscitation efforts have been withdrawn.

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References
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British Committee for Standards in Haematology (2004) Guidelines for the use of fresh-frozen plasma, cryoprecipitate and cryosupernatant, British Journal of Haematology, 126, 11- 28

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Gonzalez, EA, Moore, FA, Holcomb, JB, Miller, CC, Kozar, KA, Todd, SR, Cocanour, CS, Balldin, BC, McKinley, BA (2007). Fresh Frozen Plasma Should be Given Earlier to Patients Requiring Massive Transfusion. The Journal of TRAUMA Injury, Infection, and Critical Care. 2007; 62 (1):112-119

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Hellstern, P, Haubelt, H (2002). Indications for plasma in massive transfusion. Thrombosis Research, 107 (2002) S19-S22

Hiippala, ST (1998). Replacement of massive blood loss. Vox Sanguinis, 74 (Suppl. 2), 399-407

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Ketchum, L, Hess, JR, Hiippala, S (2006). Indications for early fresh frozen plasma, cryoprecipitate, and platelet transfusion in trauma. The Journal of Trauma Injury Infection and Critical Care. Supplement 2006. Volume 60, number 6, S51-S58

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Malone, DL, Hess, JR, Fingerhut, A (2006). Massive transfusion practices around the globe and a suggestion for a common massive transfusion protocol. The Journal of Trauma Injury Infection and Critical Care. Supplement 2006. Volume 60, number 6 S91-S96

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Mikhail, J (2004). Massive transfusion in trauma: process and outcomes. Journal of Trauma Nursing. 2004

Moltzan, CJ, Anderson, DA, Callum, J, Fremes, S, Hume, H, Mazer, CD, Poon, MC, Rivard, G, Rizoli, S, Robinson, S (2008). The evidence for the use of recombinant factor VIIa in massive bleeding: development of a transfusion policy framework. Transfusion Medicine, 18, 112–120

Royal Children’s Hospital – Massive Transfusion Protocol (2005) Laboratory Services, Doc. No. MH-W-001, Version 2

Schwab, CW, Shayne, JP, Turner, J (1986). Immediate trauma resuscitation with type O uncrossmatched blood: a two-year prospective experience. Journal of Trauma, 26, 897- 902

Shaz, BH, Dente, CJ, Harris, RS, MacLeod, JB, Hillyer, CD (2009) Transfusion Management of Trauma Patients. Anesthesia & Analgesia. 2009;108(6):1760-1768

Spahn, DR, Rossaint, R (2005). Coagulopathy and blood component transfusion in trauma. British Journal of Anaesthesia, 95 (2): 130-139

Stainsby, D, MacLennan, S, Hamilton, PJ (2000). Management of massive blood loss: a template guideline. British Journal of Anaesthesia, 85, 487-491

Stanford Hospital & Clinics – Massive Transfusion Guidelines - Aug 2007

Tien, H; Nascimento Jr, B; Callum, J; Rizoloi, S. (2007) An approach to transfusion and hemorrhage in trauma: current perspectives on restrictive transfusion strategies. Canadian Journal of Surgery, 50(3),202-209 University Health Network (Ontario) - Policy and Procedure Manual, Massive Transfusion Protocol – Clinical

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Appendix A - Selected C.S.A. Z902-10 Standards Pertinent to Massive Transfusion
The Guideline for Massive Transfusion in Nova Scotia has been developed in compliance with the C.S.A. Standard, Z902-10, Blood and blood components. Massive transfusion — a procedure in which a recipient is transfused with an amount of blood that is approximately equal to or greater than his or her estimated total blood volume, within a 24 h period.

4 General
4.7 Process control 4.7.1 The facility shall have validated operating procedures for all activities listed in Clause 1.3 (a) through (q) to ensure the quality of its products, processes, and services. These shall include procedures for the identification, documentation, review, and approval of all process changes. The facility shall perform a re-validation whenever changes are made to a validated system that could reasonably be expected to affect the results obtained during the original validation. The comprehensiveness of validation should reflect the criticality of the process and the extent of the change being made.

9 Release, storage, packing, and transportation of blood and blood components
9.3 Release of untested blood and blood components 9.3.1 Release of blood and blood components, prior to completion of required testing, shall be done only in life-threatening situations when blood or blood components tested according to normal procedures are not available and only with the documented approval of the physician of the person receiving the transfusion. See Clause 8.4.7.

10 Requests, pre-transfusion testing, selection of components, and acceptance criteria
10.2 Requests 10.2.3 There shall be unequivocal identification of the recipient before drawing blood samples. This shall include verification of the recipient’s identification number or, if this not available, the alternative procedure in Clause 10.2.4 shall be used. If inaccuracies or discrepancies are discovered during the identification process, blood samples shall not be collected until the inaccuracies or discrepancies have been satisfactorily resolved. 10.2.4 There shall be a written procedure for the establishment of positive identification in situations where recipients do not have an identification number.
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Note: Such circumstances can occur in instances where specimens are drawn outside of the health care facility or when pre-operative tests are performed on an outpatient basis. 10.3 Recipient blood samples 10.3.2 At the time of blood sample collection, in the presence of the recipient, the tube shall be labeled and the person taking the sample shall verify that the information on the label of the sample matches the identity of the recipient. All documentation that accompanies a recipient blood sample shall contain sufficient information to unequivocally link it with the recipient and the sample. 10.7 Selection of blood components 10.7.1 Recipients shall be transfused with ABO group-specific whole blood or ABO group-compatible red blood cells. 10.9 Special circumstances 10.9.1 Infants under four months 10.9.1.9 In the case of massive transfusion including exchange transfusion, only red blood cells that have been screened and found negative for hemoglobin S should be transfused. 10.9.2 Massive transfusion When a recipient receives a massive transfusion, the pre-transfusion testing may be abbreviated, provided the abbreviated testing is in accordance with policies and procedures established by the medical director. 10.9.3 Emergency transfusion 10.9.3.1 In situations where delaying a transfusion may be deleterious to the recipient’s condition, whole blood or blood components may be released without the infectious disease tests and pre-transfusion testing required under Clauses 8.4 and 10.6; nonetheless, Clause 9.3 shall apply. Whole blood or red blood cells should be Rh-negative for (a) children; and (b) women of child-bearing age. 10.9.3.2 Recipients with an undetermined ABO group shall receive group O red blood cells. 10.9.3.3 ABO group-specific whole blood or ABO group-compatible red blood cells may be transfused prior to completion of other tests for compatibility if the recipient’s ABO group has been determined by the transfusing facility without reliance on previous records.

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10.9.3.4 If pre-transfusion testing has not been completed, a label shall be affixed to the product that clearly indicates that pre-transfusion testing had not been completed at the time of release. 10.9.3.5 Transfusion records shall include a signed declaration by the requesting physician confirming that the clinical situation was sufficiently urgent to justify releasing whole blood and/or blood components before completion of pre-transfusion testing and/or any infectious disease testing. When possible, informed consent should be obtained from the recipient. 10.9.3.6 Compatibility tests should be completed promptly and any incompatibility shall be immediately reported according to written policies and procedures. Clauses 8.4.1 and 9.3.4 shall apply.

11 Transfusion of blood and blood components
11.3 Identification of recipient 11.3.1 There shall be unequivocal identification of the recipient against the information in the written request for blood and blood components, as detailed in items (a) to (e) in Clause 10.2.1. 11.5 Warming 11.5.1 If warming of whole blood or blood components is indicated, this should be accomplished during transfusion using a device that will not cause clinically significant hemolysis to occur. 11.9 Rh-immune globulin 11.9.7 Each transfusion service shall have a procedure for management of Rhnegative recipients who receive blood components containing Rh-positive red cells.

18 Adverse events
18.1 General 18.1.1 A transfusion service shall have operating procedures for documenting, reporting, evaluating, and follow-up on all adverse events. The procedures shall be consistent with the requirements of Clause 18 and shall be maintained as specified in Clause 4.6.1.6.

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Appendix B: Conflict of Interest Declaration for Massive Transfusion Working Group
Name Employment Stock Shareholder Honoraria/ Consulting Fee Grant/ Research Support Member of Advisory Panel Member Board of Directors Nothing to Disclose

Dr. Robert Green

Dr. Eiad Kahwash Dr. Blaine Kent

Dr. Samuel Minor

Dr. John Tallon Dr. Irene Sadek

Dr. Romesh Shukla

Department of Emergency Medicine QEII HSC Halifax, NS Medical Director, CBS, NS/PEI Chief, Division of Cardiac Anesthesia; Surgical Director of Perioperative Blood Management Program, QEII HSC General Surgery, Critical Care Medicine QEII HSC, Halifax, NS Medical Director, Nova Scotia Trauma Program Medical Director, Pathology & Laboratory Medicine, Department of Pathology and Laboratory Medicine, QEII HSC Chief of Woman’s & Obstetrical Anesthesia, IWK Health Centre, Halifax, NS

x

x

x

x

x x x

x

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Dr. Natalie Yanchar

Medical Director, IWK Trauma Care, Halifax, NS

x

Richard Crouse

Medical Laboratory Technologist, South Shore Health, Bridgewater, NS Program Manager, Emergency Health Services, Nova Scotia Trauma Program, Halifax, NS Conservation Nurse Coordinator, Perioperative Blood Management Program, QEII HSC, Halifax, NS Hospital Customer Service Representative, Canadian Blood Services, NS/NL Halifax, NS Regional Manager Production, CBS, NS/PEI Orientation/Education, Pictou County Health Authority, New Glasgow, NS

x

Derek LeBlanc

x

Heather Mingo

x

Colin Power

x

Michelle Rogerson Ruth Woodacre

x x

Nova Scotia Provincial Blood Coordinating Program
Dr. David Anderson Marina Hamilton Susan Cairns Clinical Advisor Manager Transfusion Practice Coordinator/Utilization

x x x

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Appendix C
PROMOTING EXCELLENCE IN TRANSFUSION MEDICINE

Nova Scotia Framework for recombinant Factor VIIa (Niastase®) Utilization in the Massive Bleeding Patient

Table of Contents
Adaptation of this Framework ......................................................................................... 24 Acknowledgements........................................................................................................... 24 Document Development .................................................................................................. 24 Background.................................................................................................................... 24 Mandate of the Working Group................................................................................... 24 Framework Development................................................................................................ 24 Other Considerations ...................................................................................................... 24 Framework ........................................................................................................................ 25 Considerations for Use ................................................................................................. 24 Recommended Dosing .................................................................................................. 24 Administration ................................................................................................................ 24 Contraindications and Adverse Events ........................................................................... 24 References........................................................................................................................... 26 Conflict of Interest Declaration ........................................................................................ 30

Adaptation of this Framework
The NSPBCP encourages the exchange and sharing of this framework for clinical and educational purposes. Please include the recommended citation below to indicate the source document. If you wish to obtain other forms and guidelines, please visit The Nova Scotia Provincial Blood Coordinating Program website at http://www.gov.ns.ca/health/nspbcp/ or contact by telephone (902) 473-8207, fax (902) 473-2589 or e-mail: nspbcp@cdha.nshealth.ca. Recommended Citation Nova Scotia Provincial Blood Coordinating Program. (2010). Nova Scotia Framework for recombinant Factor VIIa (NiaStase®) Utilization in Massive Bleeding, Halifax, NS.

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Acknowledgements
The following are acknowledged for their participation and contribution to the framework:

rFVIIa Working Group
Dr. Frank Cragg, Medical Leader (Blood Transfusion and Hematology), Cape Breton District
Health Authority, Nova Scotia

Dr. Eiad Kahwash, Medical Director, Canadian Blood Services, Nova Scotia and Prince Edward
Island

Dr. Blaine Kent, Chief, Division of Cardiac Anesthesia; Surgical Director of Perioperative Blood
Management Program, Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia

Dr. Jean F. Legare, Cardiac Surgeon, Queen Elizabeth II Health Sciences Centre, Halifax, Nova
Scotia

Dr. Eileen McBride, Division Head Immunohematology, IWK Health Centre, Halifax,
Nova Scotia

Dr. Stephen Phillips, Stroke Neurologist, Queen Elizabeth II Health Sciences Centre, Halifax,
Nova Scotia

Dr. John Tallon, Medical Director, Nova Scotia Trauma Program, Halifax, Nova Scotia Dr. Irene Sadek, Medical Director, Pathology & Laboratory Medicine, Department of Pathology
and Laboratory Medicine, Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia

Cheryl Doncaster, Hospital Customer Service Representative, Canadian Blood Services,
Halifax, Nova Scotia

NSPBCP
Dr. David R. Anderson, Clinical Advisor Marina Hamilton, Program Manager Susan Cairns, Utilization Transfusion Practice Coordinator

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Document Development
Background
Recombinant Factor VIIA (rFVIIa), also known as NiaStase® (eptacog alfa, activated), “is a genetically engineered protein” and is licensed “in Canada for hemophilia A/B patients with inhibitors to Factor VIII or Factor IX, respectively” (Moltzan et al, 2008). Clinical Practice Guidelines for rFVIIa use in hemophiliacs and patients with acquired inhibitors have been prepared by the Inhibitor Subcommittee of the Association of Hemophilia Clinic Directors of Canada (AHCDC) (“Suggestions for the Management of Hemophiliacs and Non-Hemophiliacs with Factor VIII Inhibitors”) and are available at http://www.ahcdc.ca/FVIIIsuggestions.html. Recombinant Factor VIIa has been used as treatment for unlicensed indications such as i.e., bleeding patients with platelet function defects, promotion of clot formation and to discontinue bleeding in trauma, surgery and obstetrics. The use of rFVIIa in massive bleeding patients resulted in the development of a national transfusion policy framework by the National Advisory Committee on Blood and Blood Products (NAC) to assist physicians with their decision making for the use of this product. While data on the labeled use of rFVIIa is collected through the Canadian Hemophilia and Resource Management System (CHARMS) database, monitoring of unlicensed use is very limited. Mandate of the Working Group In order to develop a Nova Scotia policy framework, the NSPBCP convened a working group with multidisciplinary representation from Nova Scotia. The rFVIIa Utilization Working Group consisted of physicians with expertise in emergency/trauma medicine, hematology, cardiology, surgery, neurosurgery and anesthesia, along with the NSPBCP Clinical Advisor, Program Manager and Transfusion Practice Coordinator/Utilization. The key objectives of the working group were: • to provide a framework for decision making in the massively bleeding patient and identify prerequisites for its use • develop tools to support the framework • to determine the data elements to be collected and monitored • to develop methods for tracking and reporting the use of rFVIIa, and patient outcomes • to provide advice on clinician education Framework Development Environmental Scan An environmental scan was conducted within Canada in order to obtain monitoring frameworks and tools, however, only the NAC framework and the product monograph were found. Development The following framework is based on the NAC article - The evidence for the use of recombinant factor VIIa in massive bleeding: development of a transfusion policy framework and Nova Scotia Guidelines for Massive Transfusion and will assist the

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physician on the medical and required conditions when considering the request for the “compassionate release” of rFVIIa. The recommendations should not be considered “guidelines,” which may imply promotion of unlicensed use as an acceptable form of therapy. They are intended to allow health care providers to deal with “compassionate” requests for rFVIIa, some of which may be valid, some of which may not. Impact Assessment While the framework will be available to all hospitals in the DHAs/IWK, the product has only been used in adult and pediatric tertiary care facilities. The potential remains for rFVIIa to be used throughout the province. Endorsement Once drafted, the framework was reviewed by the rFVIIa Working Group and feedback incorporated as appropriate. Implementation strategies were discussed and developed throughout the process. The completed document was also approved by the Program Advisory Committee, Transfusion Medicine Advisory Group, Nova Scotia Nursing Transfusion Practice Working Group, Transfusion Medicine Quality Specialists Working Group. Monitoring, Reporting and Evaluation A data collection tool has been developed to capture the use of rFVIIa when associated with massive bleeding. The data will be analyzed yearly and a report made available to the DHAs, CBS and Department of Health. Review and revisions The framework will be reviewed by the NSPBCP every three years or as new evidence and/or national frameworks become available. This framework is available on the NSPBCP website www.gov.ns.ca/health/nspbcp/. Other Considerations Hematologists or hematopathologists should be consulted in situations where rFVIIa is being administered unlabeled to ensure that all other measures to achieve hemostasis have been taken, to ensure proper dosing rFVIIa and to ensure the collection of outcome data and adverse event data. There are also significant safety concerns due to the potential risk of thrombotic events. The administering clinician and patient/surrogate decision-maker should be informed that this is an unlicensed use of rFVIIa and that there are potentially increased risks of arterial and venous thromboembolic events, especially in the following patients (Moltzan et al, 2008): History of arterial and/or venous thromboembolism (VTE) Sepsis/Disseminated Intravascular Coagulation (DIC) Hereditary thrombophilia Vascular grafts Mechanical heart valves Endotoxemia Atherosclerosis Sickle cell anemia Age > 65 years
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Framework
The Nova Scotia Provincial Blood Coordinating Program has based the Nova Scotia Framework for rFVIIa (NiaStase®) Utilization in The Massive Bleeding Patient on the NAC article ‘The evidence for the use of recombinant factor VIIa in massive bleeding: development of a transfusion policy framework’, published in Transfusion Medicine 2008.

1 Considerations for Use
Massive bleeding: rFVIIa has limited application in this situation (Berkhof and Eikenboom, 2009) because “there is little evidence to support the routine use of rFVIIa in massive bleeding on review of 13 randomized controlled trials” (Moltzan et al, 2008). Trauma patients, perioperative patients, or obstetrical patients with massive ongoing bleeding who are likely to achieve good clinical outcome may be considered for rFVIIa administration. Jehovah Witnesses patients who are massively bleeding may accept rFVIIa as part of a treatment plan. “It is recommended that rFVIIa be used only in the following clinical situations: o where randomized, controlled clinical trials have shown reasonable efficacy with reasonable risks/costs; or o where a sound rationale for the product’s use can be provided and a good clinical outcome is possible; and o the risks have been clearly explained by the administering clinician to the patient/surrogate decision-maker; and o the product is administered properly.” (Moltzan et al, 2008) rFVIIa should only be considered during massive bleeding after all other transfusion and therapeutic measures have been considered including: (Moltzan et al,
2008) (Vincent et al, 2006)

hemostatic measures – a. surgical correction of the bleeding b. correct acidosis if pH is less than 7.1 c. calcium replacement to maintain an ionized calcium greater than 1.13mmmol/L d. correct hypothermia aggressive blood component support – a. the patient has received 8 or more units of red blood cells (RBCs) in 24 hours or more than 4 units RBCs in the first hour of resuscitation (for pediatric cases, more than 1.5 times the infant/child blood volume). RBCs to maintain a hemoglobin greater than 80 g/L b. platelet transfusions to maintain a platelet count of greater than 100 x 109L for head trauma or neurosurgery patients, or a platelet count greater than 50 x 109L for all other patients c. plasma transfusions if the PTT is greater than 1.5 times normal or if the INR is greater than 1.7 d. cryoprecipitate to maintain a fibrinogen greater than 1.0 g/L administration of antifibrinolytics a. Tranexamic Acid – 10 mg/kg b. DDAVP –10 mcg/m2 (adult dose) maximum dose - 20 mcg 0.3 mcg/m2 (pediatric dose) maximum dose - 20 mcg
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There may be situations other than those listed above where rFVIIa may be indicated even if the above criteria are not met. These situations need to be assessed and approved on a case-by-case basis by the Blood Transfusion Service/Blood Bank (BTS/BB) physician based on the medical screening clinical recommendations listed above. The following questions may serve as a guide: o What is the patient clinical presentation and what is the rationale for use? o What is the amount of blood components already infused? o What are the fibrinogen level, the INR and the platelet count? For these “other” indications the requesting physician should contact the BTS/BB physician on call to provide specific criteria about the indication for requesting rFVIIa. The BTS/BB physician will determine if the prerequisites have been met and if rFVIIa should be issued. There should be a review of possible adverse situations and physician consent issues before rFVIIa is issued. Table 1 - Recommendations for Unlicensed rFVIIa Utilization Category Recommendations Trauma (Blunt or Penetrating) Insufficient Evidence to Recommend Pelvic trauma Not Recommended Cardiovascular Surgery Considered Investigational Prostatectomy Insufficient Evidence to Recommend Hematopoietic Stem Cell Transplant Not Recommended Intracranial Hemorrhage Not Recommended Liver Resection Not Recommended Liver Transplant Not Recommended Cirrhosis Not Recommended
Note: Adapted from “The evidence for the use of recombinant factor VIIa in massive bleeding: development of a transfusion policy framework” by Moltzan et al, 2008, Transfusion Medicine, 18:112–120 and “Recommendations on the use of recombinant activated factor VII as an adjunctive treatment for massive bleeding – a European perspective” by Vincent et al, 2006, Critical Care 2006, 10:R120.

2 Recommended Dosing
rFVIIa is dosed according to body weight. When selecting the dose, rFVIIa should be rounded to the nearest vial size to avoid wastage. Recommended dosing: Massive (life threatening) bleeding (trauma patients, peri-operative patients, obstetrical bleeds): Initial dose of 0.020-0.050 mg/kg. (Moltzan et al, 2008) The dose may be repeated in 30 minutes if bleeding does not stop. If bleeding continues, a third dose may be given 2 hours later (maximum 3 doses). While active bleeding continues there should be aggressive correction of coagulopathy with blood components to maintain an INR of less than 1.7, fibrinogen greater than 1.0 g/L and a platelet count greater than 50 x 109/L (platelet count greater than 100 x 109/L for CNS injuries).
It should be noted that the therapeutic range of rFVIIa for hemostasis has not been identified in tests for prothrombin time (PT), aPTT, and plasma FVII clotting activity (FVII:C). For these reasons, coagulation parameters should be used only as an adjunct to the evaluation of clinical hemostasis to monitor effectiveness and treatment schedule of rFVIIa in patients. (Novo Nordisk Canada Inc., 2009)

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3 Administration
rFVIIa is a genetically engineered protein expressed from cloned human FVII genes in baby hamster kidney cells. rFVIIa is considered less likely than human blood products to transmit infectious agents. rFVIIa is intended for intravenous bolus only and administered over 2-5 minutes. rFVIIa should not to be mixed with infusion solutions. (Moltzan et al,
2008)

Administration of rFVIIa should take place immediately. Each vial should be used within 3 hours of reconstitution. (Moltzan et al, 2008)

4 Contraindications and Adverse Events
rFVIIa should not be administered to patients with known hypersensitivity to rFVIIa or any of the components of rFVIIa. As rFVIIa contains trace amounts of mouse IgG, bovine IgG, hamster proteins and other bovine proteins, known hypersensitivity to mouse, hamster, or bovine proteins is a contraindication for use. (Novo Nordisk Canada Inc., 2009) Patients with DIC, advanced atherosclerotic disease, crush injury, septicemia, or concomitant treatment with activated or non-activated prothrombin complex concentrates may have an increased risk of developing VTE due to their underlying condition or concomitant treatment. (Novo Nordisk Canada Inc., 2009) Avoid the use of rFVIIa in refractory acidosis (persistent pH of less than 7.1)
(Moltzan et al, 2008).

Patients who receive rFVIIa should be kept under close observation for signs and symptoms of unfavorable activation of the coagulation system or Both arterial and venous thrombosis. (Novo Nordisk Canada Inc., 2009) thromboembolic adverse events have been reported after treatment with rFVIIa, mostly in patients with predisposing risk factors. Any findings of this nature indicate that the dosage should be reduced or treatment stopped, depending on the patient’s symptoms. (Novo Nordisk Canada Inc., 2009) The risk of potential interaction between rFVIIa and coagulation factor concentrates is unknown. Simultaneous use with prothrombin complex concentrates (activated or not) should be avoided. (Novo Nordisk Canada Inc., 2009) It is preferable to avoid the use of rFVIIa during pregnancy. Patients who have received rFVIIa during delivery or post partum have shown an increase risk for thrombotic events such as myocardial infarction, pulmonary embolism, deep vein thrombosis, retinal artery occlusion, or cerebral ischemia. (Novo Nordisk Canada
Inc., 2009)

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REFERENCES
American Psychological Association. (2010). Publication Manual of the American Psychological Association (6th ed.). Washington, DC: Author. Berkhof, F.F., Eikenboom, C.J. (2009). Efficacy of recombinant activated Factor VII in patients with massive uncontrolled bleeding: a retrospective observational analysis. Transfusion 2009 49:570-577 Moltzan, C.J., Anderson, D.A., Callum, J., Fremes, S., Hume, H., Mazer, C.D., Poon, M.C., Rivard, G., Rizoli, S., Robinson, S. (2008). The evidence for the use of recombinant factor VIIa in massive bleeding: development of a transfusion policy framework. Transfusion Medicine, 18:112– 120. Novo Nordisk Canada Inc. (2009) NiaStase® eptacog alfa (activated), Product Monograph, Schedule D. Mississauga, Ontario Novo Nordisk Canada Inc. (2001). RFVIIa® eptacog alfa (activated), Novo Nordisk Information for Health Care Providers. Novo Nordisk Canada Inc. (1999) RFVIIa Early Intervention and Home Treatment. Nova Scotia Provincial Blood Coordinating Program. Nova Scotia Guidelines for Massive Transfusion (2010). Halifax, Nova Scotia. Nova Scotia Department of Health Quality Framework. Background Document. (2004) Processes and Procedures Supporting the Department of Health Role in Setting Health Systems Standards. Halifax, Nova Scotia Rubinger, M., Rivard, G.E., Teitel, J., and Walker, I. (1999). Suggestions for the management of Hemophiliacs and Non-Hemophiliacs with Factor VIII Inhibitors. Prepared by the Inhibitor Subcommittee of the Association of Hemophilia Clinic Directors of Canada, 3rd ed. Vincent, J-L., Rossaint, R., Riou, B., Ozier, Y., Zideman, D., and Sphan, D. (2006). Recommendations on the use of recombinant activated factor VII as an adjunctive treatment for massive bleeding – a European perspective. Critical Care 2006, 10:R120

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Conflict of Interest Declaration for rFVIIa Working Group
Name Employment Stock Shareholder Honoraria/ Consulting Fee Grant/ Research Support Member of Advisory Panel Member Board of Directors Nothing to Disclose

Dr. Frank Cragg

Dr. Eiad Kahwash Dr. Blaine Kent

Dr. Jean F. Legare Dr. Eileen McBride

Dr. Stephen Phillips Dr. John Tallon Dr. Irene Sadek

Dr. David R. Anderson Marina Hamilton Susan Cairns

Medical Leader (Blood Transfusion and Hematology), CBDHA Medical Director, CBS, NS + PEI Chief, Division of Cardiac Anesthesia; Surgical Director of Perioperative Blood Management Program, QEII HSC Cardiac Surgeon, QEII HSC Division Head Immunohematology, IWK Health Centre Stroke Neurologist, QEII HSC Medical Director, NS Trauma Program Medical Director, Pathology & Laboratory Medicine, Department of Pathology and Laboratory Medicine, QEII HSC NSPBCP - Clinical Advisor NSPBCP - Manager NSPBCP - Transfusion Practice Coordinator

x x

x x x x x x x x x

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Clinical Guidelines
PROMOTING EXCELLENCE IN TRANSFUSION MEDICINE

Toolkit for Massive Transfusion In Nova Scotia November 2010

PRE-PRINTED ORDER
Provicial Blood Coordinating Program

Request for Blood/Blood Components for the Massive Bleeding Patient
(facilities with platelet inventory) Patient: _____________________ Allergies: _______________ Weight: _____________ KG (Pediatrics) THE FOLLOWING ORDERS: • Will be carried out by a qualified health professional ONLY ON THE AUTHORITY OF AN AUTHORIZED PRESCRIBER. • All orders to be carried out must be checked and/or completed as appropriate. An order preceded by a checkbox is only to be carried out if checked. An order preceded by a bullet is mandatory and must be carried out. • All dates must be written YYYY/MM/DD. All times must be on the 24-hour clock (hhmm) • Fax completed form to BTS.

MASSIVE BLEEDING (Complete all sections) Location of Patient (Select one only): ICU OR Emergency Other (specify)

Indication for Use: Massive Bleeding (please specify or circle) – Trauma, Surgical, Obstetrical, Medical, Other (specify)
INITIAL TRANSFUSION MANAGEMENT – (select either adult or pediatric) ADULT RBC 6 units FFP/FP 1500 mL Platelets 1 adult dose _________ mL RBC (10-15 mL per kg) _________ mL FFP/FP (10-15 mL per kg) _________ mL Platelets (5-10 mL per kg)

PEDIATRIC

I have requested the release of blood for the above patient without the completion of the required pretransfusion testing and/or compatibility. In my judgement, emergency transfusion is needed and a delay may be detrimental to this patient.

Physician’s Signature: Physician’s Name
Print

_____________Date (yyyy/mm/dd): ____________ CPSNS No. ____________

Bar Code

Original – Patient Chart

Fax Request to Blood Transfusion Service at: ###-####

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PRE-PRINTED ORDER
Provicial Blood Coordinating Program

Request for Blood/Blood Components for the Massive Bleeding Patient
(facilities without platelet inventory) Patient: _____________________________ Allergies: _______________ Weight: _____________ KG (Pediatrics) THE FOLLOWING ORDERS: • Will be carried out by a qualified health professional ONLY ON THE AUTHORITY OF AN AUTHORIZED PRESCRIBER. • All orders to be carried out must be checked and/or completed as appropriate. An order preceded by a bullet is mandatory and must be carried out. An order preceded by a checkbox is only to be carried out if checked. • All dates must be written YYYY/MM/DD. All times must be on the 24-hour clock (hhmm) • Fax completed form to BTS.

MASSIVE BLEEDING (Complete all sections) Location of Patient (Select one only): ICU OR Emergency Other (specify)

Indication for Use: Massive Bleeding (please specify or circle) – Trauma, Surgical, Obstetrical, Medical, Other (specify)
INITIAL TRANSFUSION MANAGEMENT – (select either adult or pediatric) ADULT RBC 6 units FFP/FP 1500 mL RBC ______ mL (10-15 mL per kg) FFP/FP ______ mL (10-15 mL per kg)

PEDIATRIC

PLATELETS

Platelets are NOT required as the patient will be transferred

Request Platelets from CBS (Select either adult or pediatric) □ Adult 1 adult dose □ Pediatric _______ mL (5-10 mL per kg)

I have requested the release of blood for the above patient without the completion of the required pretransfusion testing and/or compatibility. In my judgement, emergency transfusion is needed and a delay may be detrimental to this patient.

Physician’s Signature: Physician’s Name
Print

_____________ Date (yyyy/mm/dd): ____________ CPSNS No. ____________

Bar Code Original – Patient Chart Fax Request to Blood Transfusion Service at: ###-####

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PRE-PRINTED ORDER
Provicial Blood Coordinating Program

Request for rFVIIa (NiaStase® ) for Massive Bleeding (Compassionate Release)
Patient: Allergies:

THE FOLLOWING ORDERS: • Will be carried out by a qualified health professional ONLY ON THE AUTHORITY OF AN AUTHORIZED PRESCRIBER. • All orders to be carried out must be checked and/or completed as appropriate. An order preceded by a bullet is mandatory and must be carried out. An order preceded by a checkbox is only to be carried out if checked. • All dates must be written YYYY/MM/DD. All times must be on the 24-hour clock (hhmm) • For all patients with of these indicators, call Blood Transfusion Services (BTS) physician (###-####). • Fax completed form to BTS. Exemption in the OR – (as per hospital policy) MASSIVE BLEEDING (Complete all sections) Location of Patient (Select one only): ICU OR Emergency Indication for Use: Massive Bleeding (specify) Recommended Dosing (Haemostatic and other measures should be taken for massive bleeding prior to requesting rFVIIa – see back of form): Patient Weight kg Initial dose of 0.020–0.050 mg/kg IV direct. This may be repeated in 30 minutes if bleeding continues. A third dose may be given up to 2 hours later for continued bleeding. Maximum 3 doses. See reverse for massive bleeding framework. Dose Order - select one of the following vial sizes - rounding to the nearest vial size: 1.2 mg (calculated dose of 0.60–1.79 mg) 2.4 mg (calculated dose of 1.80–2.99 mg) 3.6 mg (calculated dose of 3.00–4.19 mg) 4.8 mg (calculated dose of 4.20–5.39 mg)

Other (specify) _____________________________

Physician’s Signature: Physician’s Name
Print

_________Date (yyyy/mm/dd): CPSNS No.

For Lab Use Only Indication for NiaStase use: ______________________________________ BTS Physician Approval - Signature:_____________________________________ Dose Dispensed = ________ mg 1 2 3

Bar Code Original – Patient Chart Fax Request to Blood Transfusion Service at: ###-####

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[This page is designed to go on the back of the order form. Please delete this line of text before final printing.]

The Use of rFVIIa for Massive Bleeding
Warning: With the use of rFVIIa, there are potentially increased risks of arterial & venous thromboembolic events, especially in the presence of: Age greater than 65, artificial grafts/vascular grafts, mechanical heart valves, prior history of arterial and/or venous thrombosis, history of atherosclerosis, sickle cell anemia, hereditary thrombophilic states, other acquired thrombophilic states, sepsis/endotoxemia/DIC. DEFINITION: Massive bleeding is defined as the loss of one blood volume within a 24 hour period OR 50% blood loss within 3 hours OR a rate of loss of 150 mL/min OR greater than 4 units of PRBC transfused in the first hour of resuscitation in the presence of ongoing, uncontrollable bleeding. Haemostatic and other measures to be taken for massive intractable bleeding prior to requesting rFVIIa: • Attempt to correct the coagulopathy with frozen plasma (15 mL/kg) if the aPTT is greater than1.5 x normal or the PT, measured as the INR, is greater than 1.7. rFVIIa dramatically shortens the PT and therefore after administration of rFVIIa, additional plasma should be administered to maintain the aPTT less than1.5 x normal • Platelet transfusions should be administered to target the platelet count: o Greater than 100 x 109/L for head trauma or neurosurgery and greater than 50 x 109/L for all other patients o In cardiac surgery, renal or hepatic dysfunction, platelet dysfunction can cause significant bleeding even with normal platelet counts and platelet transfusions may be appropriate o These values are not absolute and should be considered minimum standard. There may be circumstances where targeting a platelet count of 75 x 109/L is appropriate to ensure that a minimum platelet count of 50 x 109 /L is maintained at all times. Platelets are very important for the efficacy of rFVIIa. • Cryoprecipitate (1 unit/5–10 kg or 15 mL/5–10 kg) should be administered to maintain fibrinogen greater than 1.0 g/L • A fibrinogen level should be obtained first before the use of cryoprecipitate (Initial routine blood work for massive bleeds should include PT/INR, aPTT and fibrinogen). Recommended to check fibrinogen levels, PT/INR and aPTT frequently and replace with frozen plasma, cryoprecipitate and platelets based on the results when available • Maintain hemoglobin greater than 70 g/L in order to optimize hemostasis • Correct acidosis where pH less than or equal to 7.1 Additional measures/notes: • Calcium replacement should be considered if ionized calcium is below local reference values. The best replacement is IV calcium chloride (greatest amount of elemental calcium). • Correct hypothermia if present. Warm all blood products. • Avoid the use of rFVIIa in refractory acidosis (persistent pH less than 7.1) • rFVIIa can also be used for massive bleeding in Jehovah’s Witnesses patients.

Reference: Moltzan, C.J., Anderson, D.A., Callum, J., Fremes, S., Hume, H., Mazer, C.D., Poon, M.C., Rivard, G., Rizoli, S., Robinson, S. (2008). The evidence for the use of recombinant factor VIIa in massive bleeding: development of a transfusion policy framework. Transfusion Medicine, 18, 112–120.

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Nova Scotia Provincial Blood Coordinating Program Massive Transfusion/rFVIIa/octaplex® Utilization Data Collection Tool User’s Guide

www.gov.ns.ca/health/nspbcp PROMOTING EXCELLENCE IN www.gov.ns.ca/health/nspbcp

TRANSFUSION MEDICINE

        PROMOTING EXCELLENCE IN TRANSFUSION MEDICINE 
www.gov.ns.ca/health/nspbcp

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Table of Contents

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Introduction............................................................................................................... 38 General Information Regarding Data Collection ...................................................... 39 2.1 2.2 2.3 2.4 Who is required to submit data and when?....................................................... 39 What needs to be collected?.............................................................................. 39 What do I do with the data now that I have collected it?.................................. 39 Protection of Privacy......................................................................................... 39

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NSPBCP Massive Transfusion/rFVIIa/octaplex® Utilization Data Collection Tool40 3.1 Demographics ................................................................................................... 40 3.2 Data Entry ......................................................................................................... 42 3.2.1 Massive Bleeding/Patient on oral anticoagulants ......................................... 42 3.2.2 Initial Blood Work ........................................................................................ 42 3.2.3 Blood Components Transfused..................................................................... 42 3.2.4 Additional Measures Used to Achieve Hemostasis ...................................... 43 3.2.5 rFVIIa............................................................................................................ 43 3.2.6 octaplex®...................................................................................................... 43 3.2.7 Clinical Disposition ...................................................................................... 44 3.3 Signature ........................................................................................................... 44 3.4 NSPBCP Use Only ........................................................................................... 44

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NSPBCP Utilization Discard Form for rFVIIa and octaplex®................................. 45 Contact Information for Support and Feedback........................................................ 47

Appendix A Physician Registry Tool ............................................................................. 48 Appendix B Patient Log Form ........................................................................................ 49

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1 Introduction
During the development of the Nova Scotia Provincial Blood Contingency Plan, the working group identified the need for a massive transfusion guideline in order to provide guidance and standardization for the use of blood and blood components in patients who are massively bleeding. As a result, the Nova Scotia Provincial Blood Coordinating Program (NSPBCP) has
developed the Guideline for Massive Transfusion in Nova Scotia in collaboration with an expert working group consisting of the Nova Scotia Trauma Program, Canadian Blood Services, physicians, nurses, and laboratory technologists from the DHAs/IWK. Because the guideline refers to the use of octaplex® and rFVIIa, the NSPBCP has developed a concise data collection tool that will assist the data reporters in collecting this information. The data

collected through this initiative will serve to review current demand as well as the appropriateness of massive transfusion/rFVIIa/octaplex® utilization. The following information describes how to complete the Massive Transfusion/rFVIIa/octaplex® Utilization Data Collection Tool and how to submit the form to the Nova Scotia Provincial Blood Coordinating Program (NSPBCP).

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2 General Information Regarding Data Collection
Who is required to submit data and when? Each facility/hospital will collate the data, validate, and submit the data to the Nova Scotia Provincial Blood Coordinating Program (NSPBCP) on a quarterly basis. What needs to be collected? The data collection is for the utilization of blood and blood components, rFVIIa and octaplex® within Nova Scotia. The data collection form replaces the existing data collection forms for octaplex® and rFVIIa (when used for indications other than labelled use previously referred to as Group A). The administration of RBCs, FFP/FP, and platelets are reported on the form however this does not replace other reporting systems that may be submitted for utilization and/or adverse events. Utilization of rFVIIa for patients with Congenital FVII Deficiency, Hemophilia A/B with Factor VIII/IX Inhibitors or Acquired Hemophilia/Inhibitors (previously referred to as Group B) will be reported on the data collection form for these specific diagnoses (new title - Data Collection for Labelled rFVIIa Utilization: Congenital Factor VII Deficiency, Hemophilia A/B with Factor VIII/IX Inhibitors OR Acquired Hemophilia/Inhibitors). Ensure the data submitted does not contain any information whereby the identity of the patient could be determined. Please Note: There must be an entry for each facility/hospital in the province covered by data submission. If the facility/hospital has not had any massive transfusion/rFVIIa/octaplex® activity, record your hospital identifier number in the appropriate section at the top of the page and ‘No Activity for Quarter___’ in the comments section at the bottom of the page.

2.1

2.2

2.3

What do I do with the data now that I have collected it? The completed massive transfusion/rFVIIa/octaplex® utilization data collection forms are to be submitted to the NSPBCP by fax at (902) 473-2589 or mailed to the NSPBCP at: Nova Scotia Provincial Blood Coordinating Program QEII HSC - Victoria General Site 7th Floor Centennial Building, Room 7-130 1276 South Park Street Halifax, Nova Scotia B3H 2Y9

2.4

Protection of Privacy The NSPBCP’s policy on transmission of utilization information is that all documents containing “sensitive” information should be protected when transmitted. Thus, facilities submitting massive transfusion/rFVIIa/octaplex® utilization data, must not submit any data with specific patient identifying information, such as name, full birth date, address, etc.

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3 NSPBCP Massive Transfusion/rFVIIa/octaplex® Utilization Data
Collection Tool
Demographics Information on this worksheet needs to be provided only once for each record/patient entered. A record/patient will be identified using a combination of five identifiers (hospital, patient identification numbers, age, gender and year of birth). Basic patient information is entered in this section. Once information for a given patient has been entered and submitted on this worksheet, it does not need to be entered for subsequent data submissions. The exception is if a patient begins a new treatment regime for a new indication. Province ID # Enter the ID number for the province. These are the same provincial ID numbers that are used on the pages of other data collection tools such as IVIG: Province New Brunswick Nova Scotia Prince Edward Island Newfoundland and Labrador ID # 1 2 3 4

3.1

Hospital ID # Enter the hospital/site identification number that has been provided to you by the department of health/health and wellness. These numbers can also be provided by the NSPBCP. Attending Physician # Physician names are not to be sent to the NSPBCP. Enter the ordering physician’s assigned anonymous identification number. Each physician must always be referred to by the same identifying number. To assign these numbers refer to the physician registry tool and instructions in Appendix A. Specialty (Attending Physician’s) Enter the attending physician’s area of clinical service. If the physician has more than one clinical specialty, the specialty recorded should be the one they were acting as when massive transfusion/rFVIIa/octaplex® was prescribed. Should there be a need to have an area of clinical service added to the appendix, please contact the NSPBCP (contact information can be found in Section 5 of this guide). Consulting Physician # A consulting physician is a physician who is a specialist in a medical field other than that of the attending physician. Consulting physicians may be called in by the attending physician to provide opinions on various aspects of care. Physician names are not to be sent to the NSPBCP. Enter the consulting physician’s assigned anonymous identification number. Each
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physician must always be referred to by the same identifying number. To assign these numbers refer to the physician registry tool and instructions in Appendix A. Specialty (Consulting Physician’s) Enter the consulting physician’s area of clinical service. If the physician has more than one clinical specialty, the specialty recorded should be the one they were acting as when massive transfusion/rFVIIa/octaplex® was prescribed. Should there be a need to have an area of clinical service added to the appendix, please contact the NSPBCP (contact information can be found in Section 5 of this guide). Patient HCN Enter the patient’s Health Card Number (HCN) or a sequentially assigned number within the lab (for patients who do not have a HCN). Once a number (HCN or assigned number) has been assigned to a patient, the patient must always be referred to by the same identifying number. The form in Appendix B may be used to record unique patient identifiers. Year of Birth Write the year of birth only using the four digit format - “YYYY”. Example: 1972. Gender Record the gender as ‘Male’ or ‘Female’ by checking the appropriate box. Weight Record the weight of the patient which is the weight of the patient when the first dose is recorded. Enter the weight in kilograms. Date Write the date for when the massive transfusion/rFVIIa/octaplex® utilization occurred using the YYYY/MM/DD format. MTP Activated This area requests the time for the activation and discontinuation for the MTP – record as hhmm. Because this data form may be used to report octaplex® use only, this section may require a ‘no’ answer. If the patient is transferred from one facility to another, record the date and time the MTP was initiated at the receiving facility. Indicate in the comment section that the patient was transferred from another institution prior to the activation of the MTP. MTP Discontinued Enter the time when the MTP was discontinued. This may be initiated by a phone call from the team carrying out the MT or it can also be the time when blood products are no longer issued. Location Indicate where the initial order for massive transfusion/rFVIIa/octaplex® was generated by checking the appropriate box, i.e. if the MTP was initialed in Emergency and then continued in the Operating Room (OR), indicate Emergency in this area and make a notation in the comment section advising the patient was transferred to the OR.
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3.2

Data Entry

3.2.1 Massive Bleeding/Patient on oral anticoagulants The Massive Transfusion/rFVIIa/octaplex® Utilization Data Collection Tool is to be completed for the patient who has Massive Bleeding OR who is on oral anticoagulants requiring medical intervention. One of these two areas are required to be answered ‘yes’ while the other area will require a ‘no’ answer. For the section on ‘massively bleeding’, indicate by checking ‘no’ or ‘yes’. If ‘yes’, specify by checking the appropriate cause/area. If the massive bleeding episode is not occurring in the areas mentioned, check ‘other’ and specify the specialty. For the section ‘patient on oral anticoagulants’, indicate by checking ‘no’ or the appropriate box for Coumadin/Sintrom/other. If the patient is on medications such as ASA, Heparin Na or Low Molecular Weight Heparin (Fragmin®/Dalteparin, Lovenox®/Enoxaparin Na, Innohep®/Tinzaparin Na, Orgaran®/Danaparoid), indicate this as ‘other’ and specify the name of the medication on the space provided. Indicate if the patient is actively bleeding or requiring an urgent surgery/invasive procedure as well as specifying the surgery or procedure. Write the date of the surgery/procedure using YYYY/MM/DD format. 3.2.2 Initial Blood Work Check the appropriate box indicating if the hemoglobin, platelet and fibrinogen counts were completed when the MTP was initiated. The INR result is required and recorded in the space provided. For patients who have Congenital Factor Deficiencies, insert N/A where the INR is requested. 3.2.3 Blood Components Transfused Blood/Blood Components transfused – Because this form may be used to report the use of octaplex® only, the patient may not require blood products thereby the reporter should check ‘no’ to indicate that the patient did not receive blood products. If the patient received blood and/or blood components, indicate by checking ‘yes’ and completing the next area in this section. Please complete the time from when the injury/bleeding started to the time the first blood product was transfused. This could also be the time period from when the MTP was activated to the time the first blood product was transfused depending on the situation. Initial Transfusion Management – Time from injury/bleeding to initial transfusion: This is the time delay from when the order was placed in blood transfusion services to when the first unit was transfused. The time of injury may not be known, therefore, the time would be when the patient presents in the trauma/emergency department. Indicate the volume of product the patient received along with the blood group. If the patient was transferred from one institution to another with blood and/or blood components infusing, please include these products in the volumes for Initial Transfusion Management (if the volumes are unknown, indicate in the comment section). If blood products were not issued, indicate by filling in a ‘0’ for the units transfused. Platelets were requested from CBS – If your hospital does not inventory platelets and the clinician has requested platelets be ordered in from CBS, please indicate ‘Yes’. If platelets were not ordered from CBS or if your hospital has platelets, please indicate ‘No’ in this section.
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# of units requested from CBS - Provide the number of units that were ordered from CBS. If the clinician did not request platelets, write ‘0’ in the space provided for the number of units requested. Blood Products Transfused After the Initial Units (within 24 hours) – Indicate if the patient continued to receive additional blood products after the initial transfusion by checking ‘no’ or ‘yes’. Indicate if the blood products were group specific and complete the total volume (units) of blood products the patient received. If blood products were not issued, indicate by filling in a ‘0’ for the units transfused. 3.2.4 Additional Measures Used to Achieve Hemostasis The patient may have received other hemostatic treatment such as Tranexamic Acid, DDAVP and/or Vitamin K. Check all that apply. It may be necessary to access the patient’s chart in order to know if the patient received any of these measures. If any other measures were employed such as cell salvage, indicate this in the comment section. 3.2.5 rFVIIa Prevention strategies – Although it is recognized that rFVIIa is not necessarily indicated for these scenarios, the purpose of the data collection form is to collect data. Please indicate if the rFVIIa was transfused for the situations listed. If the situation is not listed, please check ‘Other’ and specify the scenario. Time from first blood product transfusion to rFVIIa use – Please indicate the time frame from when the rFVIIa was administered after the blood products were transfused. If the patient did not receive any blood products prior to the rFVIIa, indicate by filling in the time as ‘0000’. rFVIIa administered - Indicate ‘no’ or ‘yes’ by checking the appropriate box. rFVIIa initial dose – Indicate the amount of product infused in mg. Record the time the product was administered in hhmm. Dose 2 + 3 - Indicate the amount of product infused in mg. for each subsequent dose. If the patient only received a second dose, complete the amount for Dose 2 and record ‘0’ for Dose 3. Record the time the product was administered in hhmm for the appropriate dose. 3.2.6 octaplex® Congenital Factor II or X Deficiency - Patients with a deficiency of factor II or X may require octaplex® for the replacement of these factors. Indicate by checking ‘No’ or ‘Yes’ in the appropriate box and write the specific deficiency for which the patient is receiving the octaplex® in the space provided. Vitamin K Deficiency – Check the appropriate box if the patient has a diagnosis of vitamin K deficiency. octaplex® administered – Indicate by checking ‘no’ or ‘yes’ whether the patient received octaplex®. Enter the time the octaplex® was given to the patient. octaplex® initial dose - Enter the amount of octaplex® administered in mLs. Post INR/Time– Enter the result of the INR along with the time the INR was collected from the patient. Please be aware that the INR may be repeated by using the Point of Care device (PoC) which will then not be available on the lab system. In this case, refer to the progress notes in the patient chart to obtain the post INR result. For patients who have Congenital Factor Deficiencies, insert N/A where the INR is requested.
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Dose 2 - Enter the amount of octaplex® administered in mLs, if appropriate. Post INR/Time - Enter the result of the INR along with the time the INR was collected from the patient. Please be aware that the INR may be repeated by using the PoC which will then not be available on the lab system. In this case, refer to the progress notes in the patient chart to obtain the post INR result. For patients who have Congenital Factor Deficiencies, insert N/A where the INR is requested. Dose 3 - Enter the amount of octaplex® administered in mLs, if appropriate. Post INR/Time - Enter the result of the INR along with the time the INR was collected from the patient. Please be aware that the INR may be repeated by using the PoC which will then not be available on the lab system. In this case, refer to the progress notes to obtain the post INR result. For patients who have Congenital Factor Deficiencies, insert N/A where the INR is requested. Vitamin K® administered - Indicate ‘No’ or ‘Yes’ in the box provided. Record the dose administered in mg. For patients who have Congenital Factor Deficiencies, insert N/A where the INR is requested. 3.2.7 Clinical Disposition Patient survived - Check ‘No’ or ‘Yes’ in the appropriate box. It is understood that the data entered is up to the reporting time. If the patient’s condition changes after the data has been submitted, please forward this data to the NSPBCP. Date of Death - Record the date of death as appropriate using the YYYY/MM/DD format. Bleeding stopped – Indicate if the bleeding was stopped as a result of the actions taken. Patient Discharged – Indicate if the patient has reached a level of wellness at the time of reporting to have been discharged from the hospital. Comments - This section is provided for the reporter to add comments that may be pertinent as to the reason the patient received the product. This area may be used to explain the use of the product in patients which may otherwise be considered inappropriate.

3.3 Signature
Sign the data reporting form. This provides a method of contacting/tracing the individual who completed the form.

3.4 NSPBCP Use Only
This section will be used by the NSPBCP for the purpose of identifying if the use of the various products mentioned on the data form were used labelled/unlabelled in accordance to the guideline.

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4 NSPBCP Utilization Discard Form for rFVIIa and octaplex®
` Octaplex® and rFVIIa discard activity is to be reported quarterly even if there has not been any rFVIIa or octaplex® discarded in the quarter. Please complete the form and fax to the NSPBCP at (902) 473-2589. Note: As of 2008, all facilities are required to submit discard data. Hospital ID # Enter the hospital or site-specific number that has been provided to you by your respective department of health/health and wellness or by the NSPBCP. These are the same hospital ID numbers that are used on the other pages of the data collection tool. Be sure to include any leading zeros. Reporting Period Check the appropriate quarter for which the discard activity is being submitted. Write the year on the line as indicated. No Discards to report for this quarter Check this box if your hospital has not had any discard activity for the quarter. Product (rFVIIa/octaplex®) Indicate which product the information is being reported on. Date of Discard Record the date of the discard. Use the format “YYYY/MM/DD”. Amount of Discard Enter the amount discarded in mg. or mLs as appropriate. Reason for Discard To specify the reason for the discard, use the list to select the appropriate code. A guide to the reasons and their codes are shown on the worksheet and in the following table: Reason for Discard Broken Expired Spiked Not Transfused/Sterility/Integrity Of Product Compromised Returned To Lab Temperature/Visually Unacceptable Pooled, Not Used In-Lab Temperature/Visually Unacceptable Disposal Required By CBS Incorrectly Reconstituted Reconstituted, Not Used Product Failed To Reconstitute Properly
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Origin To specify the origin of the discard, use the list to select the appropriate code. A guide to the origins and their codes are shown on the worksheet and in the following table: Origin (Location) of Discard Blood Transfusion Service/Blood Bank Lab Floor Intensive Care Unit Operating Room/Recovery In transit to Floor/Unit In transit from CBS/another facility Patient Return Physician Ordering rFVIIa/octaplex® Insert the code number that has been assigned to the physician. Comments This space is provided in order to allow the reporter to give further information/clarification on the product discard. Signature Sign the form upon completion. Your signature allows the NSPBCP to contact the reporter should clarification be required. Code A B C D E F G

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5

Contact Information for Support and Feedback

If you have any questions or feedback regarding the collection or submission of octaplex® utilization data, please contact one of the following people at the NSPBCP: Sue Cairns, Utilization Transfusion Practice Coordinator E-mail: susan.cairns@cdha.nshealth.ca Phone: (902) 473-8383 Graham Wile, Senior Systems Analyst E-mail: graham.wile@cdha.nshealth.ca Phone: (902) 473-2167 Judi Bell, Research Coordinator E-mail: judi.bell@cdha.nshealth.ca Phone: (902) 473-8345

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Appendix A

Physician Registry Tool

The Nova Scotia Provincial Blood Coordinating Program (NSPBCP) does not collect physician names as part of data collection. Instead, unique numerical identifiers will be used by hospitals/facilities to link records with physicians. Each physician must always be referred to by the same identifying number. A tool has been developed and is shown in Figure 1. An electronic version of the tool can be obtained from the NSPBCP by contacting Graham Wile (902-473-2167). The physician registry tool includes the following areas: • Physician's Last Name, First Name • Physician Registration Number (provincially-assigned physician ID number) • An assigned anonymous physician ID number (unique to each physician and used by your facility to identify physicians in data submissions) Use the assigned anonymous physician ID number from the registry tool to populate the “ordering physician” column in the octaplex® data collection tool. Note: Hospitals currently using the Physician Registry Tool for IVIG should apply the same anonymous physician ID number when reporting octaplex® and rFVIIa utilization. Figure 1: Sample of Physician Registry Tool Last Name First Name Registration Number Anonymous Physician ID 000001 000002 000003 000004 000005 000006 000007 000008 000009 000010 000011 000012 000013 000014 000015 000016 000017 000018 000019 000020
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Patient Log Form

The NSPBCP does not collect patient names as part of data collection. Instead, unique numerical identifiers may be used by hospitals/facilities to link records with patients. Each patient must always be referred to by the same identifying number. A tool has been developed and is shown in Figure 2. An electronic version of the tool can be obtained from the NSPBCP by contacting Graham Wile (902-473-2167). The patient registry tool includes the following areas: • An assigned anonymous patient ID number (unique to each patient and used by your facility to identify patients in data submissions) • Patient's Last Name, First Name

Figure 2: Patient Identifier Form when Provincial Health Card not used Patient Identifiers* Last Name First Name

It is the choice of each institution whether they use a HUN or a unique sequential number for each patient; however, once an identification number is assigned to a patient, the same number must continue to be used to identify the same patient.

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Massive Transfusion/rFVIIa/octaplex® Utilization Data Collection Tool
Province ID# __________ Hospital ID# __________ Attending Physician # _____ Specialty _______________ Consulting Physician # _____ Specialty _______________ Patient HCN _______________________ Year of Birth __________ Gender: [ ] Male [ ] Female Weight __________ (kg) Date _______________ (YYYY/MM/DD) Location: [ ] Emerg. MTP Activated [ ] No [ ] Yes - Time __________ (hhmm) MTP Discontinued - Time __________ (hhmm) MT [ ] Guide Followed [ ] Guide Not Followed NSPBCP Use Only octaplex® [ ] L ________ (Initials) [ ] UL-I _________ (Date) [ ] UL-N rFVIIa [ ] Unlabelled - Supported by Framework [ ] Unlabelled – Not Supported by framework

[ ] ICU [ ] OR [ ] Floor [ ] Clinic [ ] Other ______________

Massive Bleeding: [ ] No [ ] Yes – specify: [ ] Trauma [ ] Surgery [ ] Obstetrics [ ] Medical/Other - Specify ___________________________ Patient on oral anticoagulants: [ ] No [ ] Coumadin [ ] Sintrom [ ] Other _____________ [ ] Actively Bleeding [ ] Requiring urgent surgical or invasive procedure Specify procedure ________________________________ Date of Procedure __________ (YYYY/MM/DD) Initial Blood Work - Check if completed: Hemoglobin – [ ] No [ ] Yes Platelets – [ ] No [ ] Yes INR Results

D A T A E N T R Y

Fibrinogen – [ ] No [ ] Yes

Blood/Blood Components transfused [ ] No [ ] Yes - Specify: Initial Transfusion Management: Time from injury/bleeding to initial transfusion: ______ (hhmm) aFFP/FFP/FP _____ mL (Group __) RBC ____ units (Group __) Platelets ___ units (Group __) Platelets were requested from CBS - [ ] No [ ] Yes # of units requested from CBS ______

[ ] N/A

Blood Products Transfused After Initial Units (within 24 hours) [ ] No [ ] Yes – Specify: Group Specific [ ] No [ ] Yes FFP/FP - # of units _____ aFFP - # of units _______ RBCs - # of units _____ Platelets - # of units _____ Cryoprecipitate - # of units _____ Additional Measures Used to Achieve Hemostasis Tranexamic Acid [ ] No [ ] Yes DDAVP [ ] No

[ ] Yes

Vitamin K [ ] No [ ] Yes

rFVIIa

Prevention Strategies - [ ] INR Correction [ ] Platelet Function Defect [ ] Jehovah Witnesses [ ] Other (specify) _________________________________________ Time from first blood product transfusion to rFVIIa use: ______ (hhmm) rFVIIa administered [ ] No [ ] Yes rFVIIa initial dose ____ mg Time: ______ (hhmm) Dose 2: ____ mg. Time: ______ (hhmm) Dose 3: ____ mg. Time: ______ (hhmm) Congenital Factor II or X Deficiency [ ] No Vitamin K Deficiency [ ] No [ ] Yes [ ] Yes (Please specify): __________________

octaplex®

octaplex® administered - [ ] No [ ] Yes Time __________ (hhmm) octaplex® initial dose ______ mL Post INR _______ Time: _________ (hhmm) Dose 2 _______ mL Post INR _______ Time _________ (hhmm) Dose 3 _______ mL Post INR _______ Time _________ (hhmm) Vitamin K® administered [ ] No [ ] Yes Dose __________ mg.

Clinical Disposition: Patient survived [ ] No [ ] Yes Date of death ___________ (YYYY/MM/DD) Bleeding stopped [ ] No [ ] Yes Patient discharged [ ] No [ ] Yes Comments:

Signature ___________________________________________

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NSPBCP UTILIZATION DISCARD FORM (rFVIIa/octaplex®)
Hospital ID # ________ Reporting Period: [ ] Quarter 1 = Apr 1 – Jun 30 __________ [ ] Quarter 2 = Jul 1 - Sep 30 YEAR [ ] Quarter 3 = Oct 1 - Dec 31 [ ] Quarter 4 = Jan 1 – Mar 31

No discards to report for this quarter. Product (rFVIIa/octaplex®) Date of Discard (YYYY/MM/DD) Amount of Discard (mg/mL) Reason For Discard Origin Physician Ordering Product

Reasons for Discard Broken Expired spiked not transfused/sterility/integrity of product compromised returned to lab temperature/visually unacceptable pooled, not used in lab temperature/visually unacceptable disposal required by CBS incorrectly reconstituted reconstituted, not used

Code A B C D E F G H I

Origin (Location) of Discard Blood Transfusion Service/Blood Bank Lab Floor Intensive Care Unit Operating Room/Recovery In transit to Floor/Unit In transit from CBS/another facility Patient Return

Code A B C D E F G

Comments:

Signature: __________________________________________
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FACILITY NAME ADDRESS BLOOD TRANSFUSION SERVICE

Massive Transfusion Procedure DISCLAIMER: This policy and procedure is approved for use within the (FACILITY NAME OR DISTRICT) Blood Transfusion Service (BTS) facilities ONLY. No liability will be assumed for its use outside the (FACILITY NAME OR DISTRICT). Any facility wishing to use this resource should carefully assess their specific needs before incorporating this document in whole or part. If any part of this document is used the (FACILITY NAME OR DISTRICT) BTS requests that applicable credit be included in the reference listing. (NAME OF LABORATORY. APPROVED BY: NAME & SIGNATURE MEDICAL DIRECTOR TECHNICAL MANAGER SUPERSEDES: REVIEWED BY: NAME SIGNATURE DATE DATE
DD/Month/YYYY DD/Month/YYYY

Date Removed from Service:
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FACILITY NAME ADDRESS BLOOD TRANSFUSION SERVICE

Massive Transfusion Procedure PURPOSE • To outline a policy and procedure that enables a standardized blood therapy and data collection response to activation of a Massive Transfusion Protocol for the treatment of patients categorized as massively bleeding, in accordance with the Guideline for Massive Transfusion in Nova Scotia. SCOPE This policy and procedure **applies to all processes required to enact a Massive Transfusion Protocol within the Blood Transfusion Service (BTS), which includes but is not limited to request, communication, selection, preparation, dispense, utilization monitoring and reporting related to massive transfusion. ** [you may choose to separate policy and procedure based on practice]

RELATED POLICIES/PROCEDURES [List facility related SOPs] SOP RELATED POLICIES/PROCEDURES [INSERT FACILITY SPECIFIC INFORMATION] [TRANSPORT OF BLOOD AND BLOOD COMPONENTS] SOP-XXX [TRANSPORT WITH PATIENT} SOP-XXX [CBS Ordering and Receiving ] SOP-XXX [Receiving verbal orders ] SOP-XXX [Thawing Plasma] SOP-XXX [Emergency Release] SOP-XXX [Group Screen Crossmatch] SOP-XXX [Visual Inspection] SOP-XXX [Selection of Components/Products] SOP-XXX Enter others as relevant to facility processes SOP-XXX FORM NAME [List facility related forms] FORM [MTP UTILIZATION REPORTING FORM] FORM –XXX [EMERGENCY RELEASE APPROVAL FORM ] FORM-XXX [CBS INVENTORY REQUEST FORM] FORM-XXX [ MTP LOG] FORM-XXX [RISK BENEFIT ANALYSIS] FORM-XXX SUPPORTING DOCUMENTS GUIDELINE FOR MASSIVE TRANSFUSION IN NOVA SCOTIA CBS VISUAL INSPECTION GUIDE CBS CLINICAL GUIDE TO TRANSFUSION APPENDIX A PRE PRINTED ORDER FROM APPENDIX B MTP ALGORITHM

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FACILITY NAME ADDRESS BLOOD TRANSFUSION SERVICE

Massive Transfusion Procedure

OBJECTIVE The objective of this procedure is to document a process to support a consistent response by the BTS to MTP activation requests. The response is to: • reflect accepted practice in the management of massive blood loss as per the provincial guideline • generate data using the utilization reporting form, for all patients transfused with a massive transfusion package or its’ equivalent within a 24 hour period • involve the medical director as needed • describe modifications to laboratory testing of massively transfused patients FREQUENCY: As required

MATERIALS REAGENTS [EXAMPLES] As per related SOPs List all unique items

SUPPLIES/EQUIPMENT As per related SOPs List all unique items

QUALITY CONTROL: As per related SOPs Blood components and products determined to fail any elements of QA as per related SOPs may be used at the discretion of the medical director, should the outcome of a risk benefit analysis favor its’ usage. All decisions must be documented within the quality system, use Form XXX Risk/Benefit Analysis. [Enter what you would use to document decisions related to QS failures, to override/allow inventory to be used]. DEFINITIONS: Massive Transfusion – A procedure in which a recipient is transfused with an amount of blood that is approximately equal to or greater than his or her estimated total blood volume, within a 24 h period. (CSA Z902-10)

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FACILITY NAME ADDRESS BLOOD TRANSFUSION SERVICE

Massive Transfusion Procedure [Depending on your QS you may choose to have a separate policy, here is some policy like statements to consider]. POLICY STATEMENTS FOR MTP STEP STATEMENT 1 Verbal Requests to activate the MTP are accepted and managed in an urgent manner. 2 Pre-printed order forms/ facility forms are available to requisition components and document the physician’s awareness and acceptance of unmatched components. 3 The BTS medical director is notified as per facility policy. 4 INITIAL TRANSFUSION MANAGEMENT is referred to as the MTP Package and will include scenario A or B, as follows: A. Facilities that inventory platelets PEDIATRICS: 10-15 mL/kg RBC, 10-15 mL/kg FFP/FP, 5-10 mL/kg platelets

ADULTS: 6 units of RBCs, 1500 mL plasma, 1 unit of platelets

5 6

7 8

9

B. Facilities that do not inventory platelets ADULTS: PEDIATRICS: 6 units of RBCs, 10-15 mL/kg RBC, 1500 mL plasma 10-15 mL/kg FFP/FP SCENARIO B: BTS will submit an urgent request to CBS for platelets as directed by the primary care physician, document action on the MTP log FORM XXX It is contraindicated to order platelets for patients being transferred for treatment; except when approved by the medical director. Selection of ABO /Rh group • O Red Blood Cells • AB Plasma containing components( FFP/FP and PLTS) Exception: When possible, select Rh negative Red Blood Cells for : • Women of child bearing age and Children All MTP component/product selection will be converted to patient ABO/Rh specific or compatible transfusion as soon as a patient group/type is known. Additional blood components/products may be requested. • The BTS medical director is aware of the Treatment goals, as per the Guideline for Massive Transfusion in Nova Scotia and may choose to discuss additional requests with the primary physician when indicated. MTP utilization reports will be completed when: • Requests for MTP activation are received • Treatment of a bleeding patient within a 24 hr period equates to the MTP package (step 5).
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NSPBCP Toolkit for Massive Transfusion in Nova Scotia November 18, 2010

SOP XXX. Page 1 of 8

FACILITY NAME ADDRESS BLOOD TRANSFUSION SERVICE

STEP 10

Massive Transfusion Procedure STATEMENT Completed, MTP UTILIZATION REPORTING FORMs are to be faxed to the NSPBCP office quarterly. (Fax to 902- 473-2589)

PROCEDURE FOR MTP STEP ACTION 1 Accept verbal notification to activate the MTP. Simultaneously request • a pre- printed order form or physician’s order form (Appendix A) OR • an emergency release form to be faxed to the BTS at ###-####.,[as per facility available forms for requests, describe process for emergency request] 2 Retrieve a copy [e- or paper- describe process] of Form XXX, MTP Log, from [fill in location] Document and Communicate the MTP Activation Request on the MTP Log, include: • Patient information (identification and reason for request) • Location (request phone/ fax number) • Lead clinician/physician • Pre-printed order or physician’s order form received 3 Notify BTS Medical Director as per facility policy and document on Form XXX, MTP 4 Depending on available patient information perform a patient blood bank history check, document findings. 5 Verify approval to dispense unmatched components has been received. Approval can occur in the following ways: • Approval may be documented on the pre-printed order ,verify the PPO has been received in the BTS and signed by the physician OR • Fax emergency release Form XXX to lead clinician/physician to sign and fax back to BTS. Indicate pre-transfusion testing will follow and ABO of RBC units has been confirmed. 6 Prepare MTP package as per MTP Algorithm (Appendix B) or see number 4 in policy statements above. • Immediately thaw FFP/FP • Follow all related SOPs to prepare components and package for transport. 7 Generate labels to attach to MTP Package, blood components and transport container(s). • Consider all related SOPs • ASSURE LABELS INDICATE EMERGENCY RELEASE - NO PRETRANSFUSION TESTING HAS BEEN PERFORMED 8 Prepare transport container(s) as per SOP-XXX 9 Pack container(s) with MTP components as per SOP-XXX
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FACILITY NAME ADDRESS BLOOD TRANSFUSION SERVICE

STEP 10 11 12 13 14 15

16

17 18

19

20 21 22

23 24

Massive Transfusion Procedure ACTION Arrange to have MTP package collected as per SOP-XXX, document name and time of contact on Form XXX, MTP Log. Label container clearly and deliver as urgent! Phone location (see step 2) to inform them MTP package has been released from BTS, document on Form XXX, MTP Log. Perform ABO/Rh grouping on patient as soon as specimen is received as per SOP-XXX Issue group specific/compatible components as soon as possible. Perform antibody screen and compatibility testing on patient sample as per facility process reference SOP/POLICY [This will vary depending on e-xm, ABO spin, full xm practice, list SOPs]. Communicate compatibility findings: • When/if performed (depends on your process, e-xm, immediate spin..) to the treatment area in a timely manner • Incompatible findings shall be communicated immediately as per SOP XXX Document communication on Form XXX, MTP Log Continue to respond to requests for components/products. Abbreviate pre-transfusion testing, as established and agreed upon by the medical director, once a patient has been transfused with a blood volume approximately equal to or greater than their own. List your practice ref SOP XXX,[ may be irrelevant if e-xm or abbreviated xm is currently in use, adjust if needed] Replenish inventory (describe processes) • Redistribution within DHA • Prepare CBS order Complete an MTP utilization report, place with reports to be faxed to the NSPBCP. Finalize computer and paper work. File Forms: • XXX MTP Log in [insert process] • XXX Emergency Release [insert process] • Copy of PPO for approval ( required in absence of Emergency Release XXX, see step 1) Request transport containers to be returned to the BTS. Verify packing/transport materials are replenished.

INTERPRETATION • Evaluate appropriateness of request by reviewing the information provided against Guideline for Massive Transfusion in Nova Scotia .Inform [medical director/supervisor as per facility process] of requests outside of the guideline recommendations. RESULT REPORTING • Collect MTP Utilization data using NSPBCP forms. Fax forms to NSPBCP as per directions on the form.
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FACILITY NAME ADDRESS BLOOD TRANSFUSION SERVICE

Massive Transfusion Procedure CORRECTIVE ACTION • Submit copies of inappropriate requests and waste to the BTC for review • Generate a nonconformance report (NCR) or…as per facility process to enter into QS

REFERENCES

American Association of Blood Banks. (2008) Standards for Blood Banks and Transfusion Services: 25th edition.

Canadian Standards Association. CSA Standard Z902-10 (2010) Blood and blood components. Mississauga, Ontario.Canadian Society for Transfusion Medicine. (2007) Standards for Hospital Transfusion Services, Version 2

Nova Scotia Provincial Blood Coordinating Program (2010) Guideline for Massive Transfusion in Nova Scotia Halifax, NS Roback, John D. (2008) American Association of Blood Banks Technical Manual, 16th edition. Bethesda, MD

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FACILITY NAME ADDRESS BLOOD TRANSFUSION SERVICE

Massive Transfusion Procedure

Written by: Wendy Varrence, Laboratory Standards Coordinator

Date: October, 2010

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Facility Name/ DHA/IWK Massive Transfusion Protocol Log
Notification of MTP Received by ________________________________________________________ Date ________________________________Time_________________________ Lead Physician/clinician Patient _______________________________________ Name_________________________________ Phone /Fax P:_________________/F:__________________ Date of Birth___________________________ MRN/HCN____________________________ Location______________________________

BB Sample status________________________ BB History check:______________________ ABO/Rh tested at_________By_:_______________ ABO/Rh Result:_________________________ Emergency Release Form/ PPO Faxed to__________________________by__________________at________________________________ Received by___________________________________at________________________________________ Reason for request: Patient for transfer: yes / no / unknown Platelet Request/ Order:

Medical Director Informed? _________________Date:_____________ Time:________ Initials:______ MTP package prepared by: _______________________________________________________________

Accession number(s):____________________

Accession number(s)

________________________________
RBCs

__________________
Thaw start_____________ Finish____________ FFP/FP(volume)

Accession number(s)

____________ ____________
Platelets

MTP packaged for transport at_______________ Pick-up/Transport details ____________________ By:_______________________________________ __________________________________________ Additional Communication ( Include date / time /initials and name of person contacted)

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