Professional Documents
Culture Documents
26/03/2012 Date of First Issue 01/11/2011 Approved 26/03/2012 Current Issue Date 26/03/2014 Review Date Final: 2.08 Version Yes / No DD / MM / YYYY EQIA Dr Anthony Byrne Author / Contact Group Committee Drug & Therapeutics Committee Final Approval This document can, on request, be made available in alternative formats
Version 2.08
Page 1 of 17
Dr. L. Fielden, Dr. A. Byrne, Dr. A. Grant, Dr. A. McKenzie, Mr. J. McCall
Date
Author
Change
Version
Version 2.08
Page 2 of 17
FOREWORD This guideline is intended to summarize treatment of acute stroke during the initial phases of diagnosis, investigation and management (i.e. the first few hours to days). They are to support non-specialist staff prior to the patient being admitted to the Stroke Unit. More comprehensive guidelines exist and can be accessed online e.g. SIGN guideline 108, NICE. This guidance is not intended to serve as a standard of medical care or be applicable in every situation. Decisions regarding the treatment of individual patients must be made by the clinician in light of that patients presenting clinical condition and with reference to current good medical practice. Subarachnoid haemorrhage, subdural and extradural haemorrhage are not dealt with in this document as they do not fall under the remit of stroke disease. National Guidelines for further reference. Scottish Intercollegiate Guidelines Network (SIGN) SIGN 108: Management of patients with stroke or TIA: assessment, investigation, immediate management and secondary prevention. December 2008. URL - http://www.sign.ac.uk/pdf/sign108.pdf National Institute for Clinical Excellence (NICE) Stroke: National clinical guideline for diagnosis and initial management of acute stroke and transient ischaemic attack (TIA). July 2008. URL - http://guidance.nice.org.uk/nicemedia/live/12018/41363/41363.pdf Where reference is made to drug therapy, further information on indications, cautions, contra-indications, side-effects and dosing can be obtained from the British National Formulary (BNF).
Version 2.08
Page 3 of 17
Airway
Breathing
Circulation
Disability D (Dextrose)
Exposure
Cognitive Function
Full clinical assessment: History & Examination. Calculate an Abbreviated Mental Test (AMT) (Age, Time, Recall address, Year, Place, Recognise 2 people, WW1, Monarch, PM, 20-1). Note the presence or absence of delirium if possible (e.g. CAM score or 4AT).
1.2
Immediate investigations
Obtain blood for FBC, U & E, LFT, CRP, glucose, cholesterol, ESR & clotting screen. Perform 12 lead ECG, in particular looking for the presence or absence of atrial fibrillation. Request Chest X-ray Request a CT brain scan (see section 1.4)
Version 2.08
Page 4 of 17
1.3
Swallow Screen
An appropriately trained member of staff should perform a water swallow test on the day of admission prior to any oral fluid, food or medication (NICE). If the patient is not sufficiently alert to cooperate, note this. Record test as failed. If failed, keep Nil By Mouth, commence intravenous fluids and arrange early Speech & Language Therapy Assessment. The patient remains at risk of aspiration. The swallow test result must be recorded in the medical notes, regardless of outcome.
1.4
CT Brain imaging
Antiplatelet agents/Anticoagulants should be withheld while awaiting brain imaging. Indications for Immediate Scanning: Potential candidate for thrombolytic therapy (refer immediately to thrombolysis protocol) On anticoagulant therapy Known bleeding tendency Reduced level of consciousness (GCS <13, where level of consciousness diminished rather than lone dysphasia) Unexplained progressive or fluctuating symptoms Papilloedema, neck stiffness or fever Severe headache at onset of stroke symptoms
For all other stroke patients: Efforts should be made to scan the patient on the day of the admission if this can be done in-hours. If presenting out-of-hours and no immediate indication (as above), a CT brain should be requested for the following morning by the admitting doctor. The requesting of a CT scan should be confirmed in the patients case notes to avoid duplicate requesting. The result of the scan should be recorded in the patients case notes.
It is the responsibility of the person requesting the CT brain to ensure the report is reviewed and acted upon e.g. administering aspirin 300mg or neurosurgical discussion, as soon as possible.
1.5
If brain imaging has excluded an intracerebral haemorrhage or complicating structural CNS lesion (e.g. tumour, abscess); Prescribe aspirin 300mg stat immediately. If unable to swallow, prescribe rectally or by enteral tube. (SIGN) Aspirin 300mg should be prescribed for 14 days on the drug prescription sheet. If aspirin allergic/intolerant: Give a loading dose of clopidogrel 300mg then continue clopidogrel 75mg daily.
After initial workup in the Emergency Department, Acute Admissions Unit or Clinical Assessment Unit patients with stroke or transient ischaemic attack (who require admission) should be transferred to the Stroke Unit as per guidance in the Operational Service Guidelines.
Version 2.08
Page 5 of 17
If unable to take clopidogrel for long term therapy, aspirin 75mg PLUS dipyridamole retard 200mg BD is the preferred option. If both aspirin and clopidogrel intolerant, dipyridamole retard 200mg BD as a single agent can be prescribed.
Version 2.08
Page 6 of 17
2.1.3 Thromboprophylaxis
The administration of anticoagulants is contraindicated during the first 24 hours after thrombolytic therapy. Anti-embolic stockings are not recommended for thromboprophylaxis after stroke (CLOTS-1 and CLOTS-2 trials). Consider a thromboprophylactic dose of low molecular weight heparin if: haemorrhagic stroke excluded AND risk of haemorrhagic transformation or bleeding into another site is assessed to be low AND the patient is at high risk of VTE (such as major restriction of mobility, previous history of venous thromboembolism, dehydration or significant co-morbidities e.g. malignant disease).
There can be difficulty with treatment as those who are immobile due to large cerebral infarcts are at risk of VTE but are also at highest risk of haemorrhagic transformation of the infarct. Decisions need to be made on an individual patient basis. Regularly review the need for thromboprophylaxis (both the need to commence therapy or to discontinue therapy when no longer appropriate).
Avoid fluctuations in blood pressure If able to swallow and no other contra-indication continue any usual blood pressure medication, unless there is good evidence that the patient has not been complying with anti-hypertensive medication pre-admission. Consider lowering BP acutely only with the following serious concomitant medical issues (NICE) Hypertensive encephalopathy Hypertensive nephropathy Hypertensive cardiac failure/myocardial infarction Aortic dissection Pre-eclampsia or eclampsia Intracerebral haemorrhage with systolic blood pressure 200 mmHg or The patient may be considered for blood pressure lowering medication if a potential candidate for thrombolysis and BP is >185/110, however, this is at the discretion of the on-call stroke specialist.
Version 2.08
Page 7 of 17
2.1.5 Statins
A statin should be prescribed to patients who have had an ischaemic stroke, irrespective of cholesterol level. Cholesterol level should still be checked on admission. Patients with ischaemic stroke on prior statin therapy should continue treatment, via a nasogastric tube, if necessary. SIGN recommends using simvastatin 40mg or atorvastatin 80mg based on the Heart Protection Study (HPS) and SPARCL trial respectively. Patients not currently prescribed a statin would usually receive simvastatin 40mg. Following clinical risk assessment by a stroke consultant atorvastatin 80mg may be recommended. Statin therapy following haemorrhagic stroke is not recommended routinely unless the risk of further ischaemic vascular events outweighs the risk of further haemorrhage.
Version 2.08
Page 8 of 17
2.2
Further investigation
2.2.3 Echocardiogram
Echocardiography is not recommended for all patients with ischaemic stroke (SIGN). Echocardiogram should be considered for patients o where clinical findings or baseline investigations (e.g. abnormal ECG) suggest cardiac disease. o with cryptogenic stroke. Hypertension without ECG abnormality is not an indication for echocardiogram. Enter as much information on the request card as possible to allow appropriate vetting of the request (e.g. ECG findings, presence of murmurs etc). If a patient has had a recent echocardiogram prior to their stroke, a repeat echo may not be appropriate. The routine use of echocardiography with contrast media for further evaluation of patients following stroke or TIA is not recommended. This should only be requested after discussion with a cardiologist.
Version 2.08
Page 9 of 17
Following brain imaging confirming intracerebral haemorrhage All antiplatelets/anticoagulants should be discontinued. A baseline full blood count and clotting screen is required (if not already done). Clotting levels in those receiving anticoagulation treatment (and have an elevated INR) should be returned to normal as soon as possible. The haematoma seen on the CT is a snapshot image and will often continue to expand following the CT scan. Discuss with the on-call haematologist the appropriate treatment to give. This will usually be a combination of prothrombin complex and intravenous vitamin K. (NICE).
While routine surgical evacuation by craniotomy is not recommended for supratentorial primary intracerebral haematoma, early neurosurgical discussion may still be required in individual circumstances. This may include younger patients with haemorrhage and subsequent pressure effects or those with very superficial haemorrhage. If there is doubt about appropriateness, then discussion should take place in order that patients do not miss out on appropriate intervention. Blood Pressure Management Consider acute management of hypertension in intracerebral haemorrhage if systolic blood pressure >200mmHg. Lowering by no more than 20% in the first 24 hours may be advisable. Intravenous labetolol or glyceryl trinirate may be options. Evidence in this area is inconclusive. Clinical Observation Regular clinical observation should be made including neuro-obs and Glasgow Coma Scale. This should be done at least hourly for the first 24-48 hours. A deterioration may indicate haematoma expansion or a re-bleed. Further CT imaging may be appropriate, particularly where neurosurgery has indicated they may accept the patient in the event of a clinical deterioration. Patients with Prosthetic Heart Valves Patients with cerebral haemorrhage and a prosthetic heart valve should also be discussed with cardiology, particularly those who need long term anticoagulation due to the valve. Patients anticoagulated solely due to atrial fibrillation who have a cerebral haemorrhage should usually have their anticoagulation fully reversed. Statin Therapy Statin therapy after haemorrhagic stroke is not recommended routinely unless the risk of further ischaemic vascular events outweighs the risk of further haemorrhage (SIGN). Subarachnoid haemorrhage and subdural and extradural haemorrhage are managed differently from primary intracerebral haemorrhage and are not covered in this guidance.
Version 2.08
Page 10 of 17
Swallowing Impairment
An early swallow screen should be performed by an appropriately trained member of staff on the day of admission prior to any oral fluid, food or medication (NICE). The swallow test result must be recorded in the medical notes, regardless of outcome. Oropharyngeal dysphagia can result in serious complications such as aspiration pneumonia, undernutrition, dehydration and missed medication. Early placement of a nasogastric feeding tube should be considered in patients identified as unable to take adequate food or medication due to a low conscious level and/or the presence of dysphagia (SIGN). This would usually be a decision made once the patient is in the Stroke Unit Aspiration +/- radiological evidence of pneumonia Aspiration is a risk of stroke and associated with poor outcome. Risk reduction - sit up and mobilise as soon as possible (NICE, SIGN) Treat for aspiration pneumonia as per the local antibiotic guidelines.
The presence of a nasogastric tube does not prevent aspiration of saliva or reflux of NG feed and aspiration. Attending staff should remain alert to the possibility of aspiration after placement.
4.1
If the patient is drowsy and unable to sit upright for 15 minutes, it is NOT SAFE to carry out a Water Swallow Test, (see flow chart below). document decision not to screen and why patient should remain Nil by Mouth with IV hydration monitor conscious level
Version 2.08
Page 11 of 17
Water Swallow Test - Part 2 Give glass with 50 ml. water to patient and observe drinking. Record observations below.
Does the patient show signs of any of the following? coughing choking (increased) breathlessness change in voice quality (hoarse and/or wet/gurgly)
First Test Second Test + 12 HRS. Third Test + 24 HRS. Fourth Test + 36 HRS.
YES
NO
YES
NO
YES
NO
YES
NO
Results
Staff signature: Staff signature: Staff signature: Staff signature:
Outcome of Water Swallow Tests PASS ( NO throughout Part I and II) FAIL ( YES at any time)
Ward/ Date
Ward/ Date
Ward/ Date
Ward/ Date
Patients PASSING the Water Swallow Test should progress to oral feeding under observation as per flow chart overleaf Patients FAILING the Water Swallow Test should be re-tested as per the chart overleaf or be referred on to SLT as appropriate
Version 2.08
Page 12 of 17
Guidelines for Referral to Speech and Language Therapy (SLT) for Assessment of Oropharyngeal Swallowing Function. Can the patient: be seated upright (in bed or chair?) remain alert and awake for at least 15 minutes?
YES
Give 1 x 5 ml teaspoon of cold water Does the patient:- fail to swallow? - cough? - choke? - become (more) breathless? Does the voice quality - change on the sound ah? - become hoarse or wet? Repeat twice (total = x 3 times) Record results on checklist
NO
Keep Nil By Mouth. Maintain full oral hygiene. Consider intravenous hydration. Refer to dietitian. Repeat screening on 12 hourly basis
Give glass with 50 ml. water to patient and observe drinking Does the patient:- cough? - choke? - become (more) breathless? Does the voice quality - change on the sound ah? - become hoarse or wet? Record results on checklist NO
Commence oral feeding free diet and fluids Carefully supervise first meal and observe eating/drinking over 2 days Ensure patient is fully upright and alert when eating/drinking If patient is noted to cough, choke, experience voice changes as above, reports difficulties, or develops a moist chest, refer to SLT Consider putting patient Nil By Mouth, particularly if chest infection develops
The above guidelines do not apply to the following groups of patients who may be referred directly to SLT: Patient is reported to have one or more of the following a history of more than one otherwise unexplained chest infection aspiration on barium swallow or other similar radiological procedure evidence of aspiration (suspected infiltrate) on plain chest x-ray. Patient has rapid and/or poorly co-ordinated respiration (may be on ventilation) and is experiencing swallowing difficulties. Patient is reporting oropharyngeal swallowing difficulties (food sticking in mouth or throat, for example). Patient has a known swallow problem (e.g., requiring modified diet) but is reported to be experiencing new problems.
Version 2.08
Page 13 of 17
Section 5:
The symptoms of a TIA usually resolve within minutes or a few hours at most, and anyone with continuing neurological signs when first assessed should be assumed to have had a stroke.
Was the event of sudden onset? y Are the symptoms focal (attributable to a single vascular territory)? Unilateral weakness and/or sensory disturbance of face, arm, leg or a contiguous combination Dysphasia y Visual Field Defect y Diplopia y Does the patient have vascular risk factors?
Stroke a clinical syndrome of rapidly developing symptoms and/or signs of focal neurological dysfunction lasting more than 24 hours with no apparent cause other than of vascular origin TIA - transient episodes of focal cerebral dysfunction or transient monocular dysfunction during which symptoms last less than 24 hours and are presumed to be of vascular origin.
3. Are symptoms/signs still present? YES Admit & treat as stroke NO - Continue risk assessment 4. Risk Assessment ABCD2 Score1 Age / Blood pressure / Clinical symptoms / Duration / Diabetes
Age Clinical Duration 60 years or over = 1, under 60 years = 0 BP Systolic BP>140 or Diastolic BP>90=1, other values=0 Unilateral weakness (face/arm/leg) = 2 OR Speech disturbance only = 1 OR Other impairment = 0 >60 min = 2, 10 to 59 min =1, <10 min = 0 Diabetes Yes = 1, No = 0
Score
0 to 3 4 to 5 6 to 7
Risk Group
Low Medium High
2 days
1.0% 4.1% 8.1%
90 days
3.1% 9.8% 17.8%
Other Factors considered High Risk: y More than 1 event in 7 days y Atrial Fibrillation yOn anticoagulants y Prosthetic Heart Valve y TIA plus neck pain suggesting arterial dissection
5. Action Plan
Office Hours - 0900h to 1600h Monday to Friday Complete Referral Form Bloods2 Contact TIA MOBILE 01324 567691 Out of Hours - 1600h to 0900h AND all day Saturday & Sunday ECG CXR3
Bloods2 ECG CXR3 Complete referral form & leave at ED reception Start appropriate secondary prevention Give Driving Advice (see below) Advise call 999 if further symptoms pending review If diagnostic doubt, significant abnormality found on basic tests, or significant co-morbidity, then use clinical judgement & admission may be appropriate
6. Other Information
Immediate Secondary Prevention Drug Regime Aspirin 300mg STAT followed by 75mg daily (If true aspirin intolerance, Clopidogrel 300mg STAT followed by 75mg daily) Drugs to be dispensed from the Emergency Department or Clinical Assessment Unit Other drug therapy (other antiplatelets, statins, anti-hypertensives etc.) will be started after clinic review
Version 2.08
Page 14 of 17
Section 6: 6.1
Special circumstances
6.2
6.3
Cerebral venous thrombosis is a rare cause of stroke, accounting for 0.5% of all strokes per annum. Diagnosing cerebral venous thrombosis is difficult and CVT are often assumed to be ischaemic infarcts. Clinical symptoms are very variable and non-specific. CT appearances can be subtly different and other imaging such as MR or CT venography may be required. The aetiology is often multifactorial and underlying thrombophilias are found in 22% of patients (SIGN). Patients with CVT should be discussed with a stroke specialist either locally or at the Western General Hospital, Edinburgh. Anticoagulation appears to be safe following cerebral venous thrombosis (despite the presence of associated secondary haemorrhage on scanning) and may be associated with an improvement in mortality and outcome (SIGN) Treatment with IV unfractionated heparin or low molecular weight heparin followed by warfarin should be considered in patients with cerebral venous sinus thrombosis (SIGN, NICE). Long term treatment with warfarin (INR range 2.0-3.0) for 6-12 months is recommended (SIGN)
Version 2.08
Page 15 of 17
6.4
Extracranial cervical arterial dissection is an uncommon cause of stroke, accounting for 2.5% of all strokes and 5-22% of strokes in young people (<45 years). The incidence of carotid artery dissection is two to three per 100,000 per year. Aetiologies include chiropractic neck manipulations & other neck trauma and arteriopathies such as fibromuscular dysplasia and cystic medial necrosis. The most likely cause of stroke in cervical artery dissection is embolism from the dissection flap. It is important to be aware of the possibility of intracranial extension of the dissection resulting in subarachnoid haemorrhage. This diagnosis should be excluded in the usual way if symptoms are suggestive prior to initiating treatment with antiplatelets or anticoagulation. (SIGN) In patients with extracranial cervical arterial dissection consider treatment with either anticoagulation for three to six months or antiplatelet agents (SIGN, NICE).
Version 2.08
Page 16 of 17
Lacunar syndromes should not affect higher cortical function Posterior Circulation Stroke (POCS) Include
Isolated homonymous hemianopia Isolated cerebellar stroke Disorders of conjugate eye movement Cranial nerve deficit with contralateral motor or sensory deficit Bilateral motor/sensory symptoms
Version 2.08
Page 17 of 17
CHI:
This document is intended to guide a clinician to administer intravenous thrombolysis for acute ischaemic stroke. The pathway attempts to identify patients who are appropriate for treatment and facilitate treatment in as short a time interval as possible. Much of the information, such as timing of symptoms, arrival and treatment and clinical information on symptoms and severity is used for audit purposes to ensure safety and effectiveness of service, and comparison with other centres. These are a national audit (NHS Quality Improvement Scotland) and an international audit (SITS-ISTR, Safe Implementation of Thrombolysis in Stroke, International Stroke Thrombolysis Register). The information is difficult to obtain retrospectively. Please fill out the paperwork as completely as possible, but without delay to treatment. Additional guidance is available through the South Scotland Telestroke Project see associated protocols. This protocol is for guidance only and is not intended to serve as a standard of medical care or be applicable in every situation. Decisions regarding the treatment of individual patients must be made by the clinician in light of that patients presenting clinical condition and with reference to current good medical practice.
Page 1 of 7
Version 2.1.5
October 2012
DoB:
CHI:
Immediate clinical assessment indicates that this patient has symptoms suggestive of a stroke.
ROSIER Scale
Has there been loss of consciousness or syncope? Has there been seizure activity [see also exclusion criteria] Is there a NEW ACUTE onset [or on waking from sleep] 1. Asymmetric facial weakness 2. Asymmetric arm weakness 3. Asymmetric leg weakness 4. Speech disturbance 5. Visual field defect Total Score:______ Yes (-1) Yes (-1) Yes (+1) Yes (+1) Yes (+1) Yes (+1) Yes (+1) No (0) No (0) No (0) No (0) No (0) No (0) No (0)
(Range 2 to +5. Stroke is unlikely but not completely excluded if total score 0)
(a) Time of Symptom Onset: (b) Time of Arrival (c) Time of Initial Assessment
Date: ___ / ___ / ___ Time: ___ : ___ hrs Date: ___ / ___ / ___ Time: ___ : ___ hrs Date: ___ / ___ / ___ Time: ___ : ___ hrs
Time Difference
(a) to (b) (a) to (c)
If the patient has been transferred to hospital rapidly, thrombolytic therapy may be possible. Assessment and imaging must be completed to allow the delivery of the initial dose within 3 hours (for selected cases within 4.5 hours see page 7). If within this time frame, continue through the following steps.
1(c) IMMEDIATE ACTIONS If the patient fulfils the above criteria, take the following steps as rapidly as possible. Where possible, tasks should be undertaken simultaneously by members of the attending staff to minimise delay. In addition, use the telestroke protocols for contacts during out-of-hours periods. 1. Check BM if low, treat urgently and reassess neurology. 2. Alert the Stroke Team (Ext 67691) and/or the on-call medical middle-grade doctor that there is a patient potentially for stroke thrombolysis. 3. Insert IV cannulae in both upper limbs 4. Send blood for FBC, coagulation screen, glucose and U&E. Other bloods should be sent as clinically indicated. Inform the laboratory that these are for a potential thrombolysis case as results are needed as an emergency before treatment can be administered. 5. Contact Duty CT radiologist/radiographer and request an immediate CT Brain scan. 6. Check temperature, pulse, blood pressure, respiratory rate 7. Perform ECG 8. Review Exclusion Criteria 9. Contact Flow Co-ordinator and inform of potential need for Critical Care bed. Critical Care medical staff should also be informed when necessary (if treatment proceeds). 10. Unless absolutely indicated, DO NOT perform arterial puncture. A CXR is not usually required before treatment and should not delay proceedings. It should be done at earliest convenience as the situation allows.
TIME IS BRAIN
The shorter the time to brain reperfusion, the greater the potential benefit and the lower the haemorrhagic risk from thrombolysis
Page 2 of 7 File with Admission Documents
Version 2.1.5
October 2012
DoB:
CHI:
CONTRA-INDICATIONS, POTENTIAL CONTRA-INDICATIONS AND CAUTIONS Circle Yes, No or Not Known as appropriate History suggestive of subarachnoid haemorrhage (even if CT normal) Yes No Not Known Seizure at stroke onset Yes No Not Known
BP Systolic <90mmHg or >185mmHg or Diastolic <40mmHg or >110mmHg Defect in coagulation Baseline BP = /
Yes
No
Not Known
On oral anticoagulant (e.g. warfarin) and INR1.4 On heparin (unless APTT within normal laboratory limits) Treatment with Low Molecular Weight Heparin or Heparinoid Treatment with a direct thrombin inhibitor Other known defect in clotting function/bleeding diathesis
Yes
No
Not Known
Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes
No No No No No No No No No No No No No No No No No No No
Not Known Not Known Not Known Not Known Not Known Not Known Not Known Not Known Not Known Not Known Not Known Not Known Not Known Not Known Not Known Not Known Not Known Not Known Not Known
Baseline BM = BM <3.0 or >22 mmol/l Neurological symptoms rapidly improving, considered likely to resolve completely within the next few hours (i.e. a transient ischaemic attack) Bacterial Endocarditis or Pericarditis NIH Stroke Scale <5 (mild neurological deficit) or >25 (see page 6) Previous stroke plus diabetes Previous intracranial haemorrhage, CNS vascular malformation, CNS neoplasm, spinal or cranial surgery, or haemorrhagic retinopathy Another stroke or head injury in the last 3 months Surgery (including liver or renal biopsy, lumbar puncture or thoracocentesis) or significant trauma (e.g. major fall at time of stroke) within previous 14 days GI, urinary, respiratory or menstrual bleeding in the last 21 days Arterial puncture at a non-compressible site in the last 10 days Patient is female and of childbearing potential (unless it is certain that pregnancy not possible) or less than 10 days post-partum Severe liver disease (hepatic failure, cirrhosis, varices etc.) Severe renal disease, including haemodialysis or peritoneal dialysis Alcohol or drug intoxication, or history of significant drug abuse Other pathology for which thrombolysis may present a significant haemorrhagic risk e.g. pancreatitis, ulcerative GI disease Patient already dependent with activities of daily living prior to this stroke event Other life-threatening illness (e.g. advanced cancer) likely to lead to death within a few months Treatment with thrombolytic agent within the last 14 days
Or History of
AGE Actilyse (rt-PA) is licensed for use in ischaemic stroke for patients aged 18 to 80 years. However, treatment may also be administered in selected patients out with this age range, although this is outside the current European labelling (ESO 2008 guideline Class III, Level C). Such treatment is at the discretion of the attending physician. Many of the above contra-indications are relative and after discussion with a stroke physician experienced in thrombolytic therapy, treatment may proceed despite their presence.
If there is significant doubt as to whether the patient is appropriate for thrombolysis, the default position is BEST USUAL CARE and do not give rt-PA
Page 3 of 7
Version 2.1.5
October 2012
DoB:
Evidence of intracranial haemorrhage Evidence of structural CNS lesion which can mimic stroke (e.g. tumour, vascular malformation or abscess) Evidence of well-established acute infarct likely to be older than 3 (4.5*) hours Large hypodensity on CT scan suggesting large infarct
Answer to ALL of the above must be No to proceed with thrombolytic therapy Scan reported by: ______________________________________ Reported in: CT scan Radiology Dept. Via teleradiology Performed Reported Date: ___ / ___ / ___ Time: ___ : ___ hrs Date: ___ / ___ / ___ Time: ___ : ___ hrs
These times are included in
5. CONSENT / ASSENT
Discussion of potential risks and benefits should take place with the patient and/or next of kin. Consent should be obtained from a capable patient (either verbal or written). If a patient is unable to give informed consent (e.g. due to dysphasia), then discussion should take place with their next of kin where possible. In such a case, or when there is no way to discuss with their next of kin in a timely manner, treatment is administered as an emergency treatment under the Adults With Incapacity Act 2000. Consent obtained from patient Assent from next-of-kin for an patient who cannot consent Not possible to obtain either consent or assent
6. CONDITIONS
1. 2. 3. 4. 5. 6.
Circle Yes or No as appropriate Treatment will be given within 3 (4*) hours of definite symptom onset Yes No INITIAL Exclusion checklist has been completed with no contra-indications present or Yes No INITIAL relative contra-indications which have been discussed and accepted Brain imaging criteria have been met Yes No INITIAL Discussion has taken place with a stroke physician experienced in Yes No INITIAL thrombolytic therapy or such a physician in attendance Consent/assent has been obtained Yes No INITIAL Critical Care Bed is or will be available Yes No INITIAL Tick appropriate box Yes No Designation: Time:
7. CONCLUSION
Is the patient to receive thrombolytic therapy? Signed: Print: Date: If YES, proceed to the Administration Protocol If NO, document reason & proceed with BEST USUAL CARE
Page 4 of 7 File with Admission Documents
Version 2.1.5
October 2012
Name:
ADMINISTRATION PROTOCOL DELIVERY OF THROMBOLYSIS NIHSS Score: _____ Actual Weight / Estimated Weight
DoB:
CHI:
See Dosage Table Ensure rt-PA prescribed on drug Kardex INITIAL _____kg INITIAL INITIAL
Total rt-PA dose 0.9mg/kg body weight to a maximum dose of 90mg Dose= weight(kg) _____ x 0.9 = _____mg See Dosage Table
Administration is by a bolus IV injection (over 1 to 2 minutes) of 10% of the total dose, followed by an IV infusion of the remaining 90% over 1 hour Bolus Dose (10%): _____mg Infusion Dose (90%): _____mg
INITIAL
Time: ___ : ___ hr on Date: ___ / ___ / ___ Time: ___ : ___ hr on Date: ___ / ___ / ___
INITIAL INITIAL
FOR MANAGEMENT OF COMPLICATIONS SEE APPROPRIATE INSTRUCTION CARD BASELINE BLOOD RESULTS (not all are necessary before treatment)
Na K Cl Urea Creatinine Glucose Hb WCC Platelets MCV Cholesterol CRP APTT APTT control PT PT control INR AST ALT Bil T Prot Alb Alk Phos
ADDITIONAL NOTES
Signed:
Page 5 of 7 File with Admission Documents
Print:
Date:
Version 2.1.5 October 2012
DoB:
PreTreatment
CHI:
2 hour 24 hour 7 day
Date Time
1a. Level of Consciousness 1b. LOC Questions
Ask patient the month and their age
0 = Alert; keenly responsive 1 = Not alert; but rousable by minor stimulation 2 = Not alert; requires repeated stimulation to attend 3 = Unresponsive; reflex movements only 0 = Answers both questions correctly 1 = Answers one question correctly 2 = Answers neither question correctly 0 = Performs both tasks correctly 1 = Performs one task correctly 2 = Performs neither task correctly 0 = Normal 1 = Partial gaze palsy 2 = Forced Deviation not overcome by oculocephalic manoeuvre 0 = Normal 1 = Partial Hemianopia 2 = Complete Hemianopia 3 = Bilateral Hemianopia (blind including cortical blindness) 0 = Normal 1 = Minor paralysis (flattened nasolabial fold, asymmetry on smiling) 2 = Partial paralysis(total or near total paralysis of lower face) 3 = Complete paralysis of one or both sides (absence of facial
movement in the upper and lower face)
2. Best Gaze
Horizontal eye movements only
3. Visual Fields
4. Facial Palsy
0 = Normal; limb holds 90 (or 45) degrees for 10 seconds without drift 1 = Drift; limb holds 90 (or 45) degrees but drifts down before full 10
seconds but does not hit bed or other support
2 = Some effort against gravity 3 = No effort against gravity; limb falls 4 = No movement UN Untestable; joint fused or amputated 0 = Normal; leg holds 30 degree position for 5 seconds 1 = Drift; leg falls by end of 5 second period but does not hit bed 2 = Some effort against gravity 3 = No effort against gravity; limb falls 4 = No movement UN Untestable; joint fused or amputated 0 = No ataxia or paralysed/comatose/does not understand 1 = Present in one limb 2 = Present in two limbs UN = Untestable only if amputation or joint fusion 0 = Normal; no sensory loss 1 = Mild to moderate sensory loss: aware of touch 2 = Severe to total sensory loss
7. Limb Ataxia
Finger/nose & heel/shin both sides. Ataxia disproportionate to weakness only
8. Sensory
9. Best Language
0 = No aphasia 1 = Mild to moderate aphasia; loss of fluency or comprehension 2 = Severe aphasia; fragmented communication 3 = Mute, global aphasia;no useable speech or auditory comprehension 0 = Normal 1 = Mild to moderate dysarthria; slurring of words,
10. Dysarthria
Criteria for Extended Time Window Thrombolytic Therapy (3 to 4 hours from onset)
Following the ECASS-3 study , benefits have been seen in selected patients treated beyond the previous 3 hour time window for thrombolytic therapy. Recommendations taking this information into account are as follows;
1
Patients with acute ischaemic stroke who are eligible for treatment with rt-PA within 3 hours should be treated as recommended in existing guidelines. Although a longer time window for treatment with rt-PA has been formally tested, delays in evaluation and initiation of therapy should be avoided because the opportunity for improvement is greater with earlier treatment. Treatment with rt-PA should be administered to eligible patients who can be treated in the time period 3 to 4.5 hours. The eligibility criteria for treatment in this period are similar to those treated at earlier period with the additional exclusion criteria: o o o o Patients older than 80 years Patients taking oral anticoagulants, regardless of the INR Patients with a baseline NIHSS>25 Patients with a history of both previous stroke and diabetes
Onset to treatment time should be minimised. The use of rt-PA in the 3 to 4.5 hour time window remains unlicensed (September 2011)
All treatments should continue to be supervised by a physician appropriately trained and experienced in the delivery of thrombolysis for acute ischaemic stroke.
Background Information - The ECASS-3 study1 was a multicentre, prospective, randomised, placebo-controlled
trial examining the efficacy and safety of thrombolysis with rt-PA in acute ischaemic stroke administered between 3 and 4.5 hours of definite symptom onset. The trial used the same dosing regimen as described above. The trial excluded patients older than 80 years, those with a baseline NIHSS>25, those taking oral anticoagulants (regardless of INR value), and those with a history of stroke and diabetes mellitus. Otherwise, inclusion & exclusion criteria were similar to those in the American Heart Association Stroke Council 2007 guidelines for thrombolysis within 3 hours. 821 patients were enrolled, 418 to the treatment group and 403 to the placebo group. 10% were treated 3 to 3.5 hours from onset, 47% were treated 3.5 to 4 hours and 39% were treated 4 to 4.5 hours. Median time was 3 hours 59 minutes. Symptomatic intracranial haemorrhage was more common in patients treated with thrombolysis . By ECASS-3 definition, it was diagnosed in 10 patients treated with rt-PA (2.4%) and 1 patient with placebo (0.2%) 2 [odds ratio 9.85, 95% CI 1.26 to 77.32, p=0.008]. By the NINDS definition, symptomatic intracranial haemorrhage was diagnosed in 33 patients treated with rt-PA (7.9%) and 14 patients given placebo (3.5%) [odds ratio 2.38, 95% CI 1.25 to 4.52, p=0.006]. A favourable outcome was more common in patients treated with thrombolysis than placebo . The frequency of the primary efficacy outcome in ECASS-3 (defined as modified Rankin Scale score of 0 to 1 at 90 days after treatment) was significantly greater with rt-PA (52.4%) than with placebo (45.2%) [OR 1.34, 95% CI 1.02 to 1.76; risk ratio 1.16, 95% CI 1.01 to 1.34; p=0.04]. The mortality between treatment and placebo groups did not differ significantly . 90-day mortality in the group treated with rt-PA was 7.7% compared to 8.4% in the placebo group (p=0.68). Treatment Benefit is strongly time dependent. The number needed to treat (NNT) to gain one more favourable outcome is 2 with treatment within 90 minutes, falling to 7 when treated within 3 hours, falling to 14 when treated between 3 and 4.5 hours. This has been consistently 3 shown in other analyses . This study, along with analysis of the Safe Implementation of Thrombolysis in Stroke International Stroke Treatment 4 Registry 3 to 4.5 hour study (SITS-ISTR 3 to 4.5 hour) , and other studies has lead to recommendations from the 5 6 American Heart Association / American Stroke Association (AHA/ASA) , the European Stroke Organisation (ESO) , 7 and the Scottish Intercollegiate Guideline Network (SIGN) which can be summarised as above.
1. 2. 3. 4. 5. 6. 7. Page 7 of 7 Hacke W et al. Thrombolysis with alteplase 3 to 4.5 hours after acute ischaemic stroke. N Engl J Med. 2008;359:1317-1329 The National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. Tissue plasminogen activator for acute ischemic stroke. N Engl J Med. 1995;333:15811587. Hacke W et al. Association of outcome with early stroke treatment: pooled analysis of ATLANTIS, ECASS and NINDS rt-PA stroke trials. Lancet 2004;363:768-74 Wahlgren N et al. SITS Investigators. Thrombolysis with alteplase 3-4.5 hours after acute ischaemic stroke (SITS-ISTR): an observational study. Lancet. 2008;372:1303-1309 del Zoppo GJ et al. Expansion of the time window for treatment of acute ischaemic stroke with intravenous tissue plasminogen activator. Stroke. 2009;40:2945-2948 ESO. Guidelines for Management of Ischaemic Stroke and Transient Ischaemic Attack 2008. URL http://www.eso-stroke.org/pdf/ESO%20Guidelines_update_Jan_2009.pdf Scottish Intercollegiate Guidelines Network. Management of patients with Stroke or TIA. December 2008. ISBN 978 1 905813 40 7. www.sign.ac.uk File with Admission Documents
Version 2.1.5
October 2012
Equipment
Actilyse Two 50mg bottles (only one needed if patient 54kg or less) Syringe for initial bolus 5ml or 10ml syringe Syringes for infusion Two 50ml luer-lock type Syringe driver capable of taking 50ml syringe Labels, needles, giving set etc.
How to administer
Open the actilyse vials only when the decision has been made to treat the patient. Dissolve the drug using the solution within the pack. If two vials needed, dissolve both bottles simultaneously to save time. Use the Dosing Chart to select the appropriate dose of Actilyse for the patient Solution concentration should be 1mg/ml Draw up the Bolus Dose a 5ml or 10ml syringe and administer intravenously over 2-3 minutes. Draw up the first Infusion Dose in a 50ml syringe, insert in the syringe driver and prime the infusion line. Set the Syringe driver to the appropriate infusion rate and start the infusion as soon as possible after the bolus has been given If a second syringe is needed (patients 64kg and above), have this drawn up and ready before the first syringe has finished. Swap syringes as soon as the first has gone through. The infusion rate for the second syringe is the same as for the first. If two bottles of Actilyse are needed, then it is easier to use one bottle for the Bolus dose and second Infusion syringe, and the other full 50ml bottle for the first infusion syringe. If during the infusion there is suspicion of an adverse reaction then stop the infusion immediately e.g. - Haemorrhage - Anaphylaxis - Oral/lingual angioedema Follow the appropriate algorithm to treat the adverse reaction. Remember that haemorrhage and oral/lingual angioedema can occur hours after the treatment has been completed.
Infusion Administration (50ml Syringes, 1mg/ml concentration) Infusion Rate* 1st Syringe 2nd Syringe (ml/hr)
40 42 44 46 48 50 52 54 56 58 60 62 64 66 68 70 72 74 76 78 80 82 84 86 88 90 92 94 96 98 100+
36.0 37.8 39.6 41.4 43.2 45.0 46.8 48.6 50.4 52.2 54.0 55.8 57.6 59.4 61.2 63.0 64.8 66.6 68.4 70.2 72.0 73.8 75.6 77.4 79.2 81.0 82.8 84.6 86.4 88.2 90.0
3.6 3.8 4.0 4.1 4.3 4.5 4.7 4.9 5.0 5.2 5.4 5.6 5.8 5.9 6.1 6.3 6.5 6.7 6.8 7.0 7.2 7.4 7.6 7.7 7.9 8.1 8.3 8.5 8.6 8.8 9.0
32.4 34.0 35.6 37.3 38.9 40.5 42.1 43.7 45.4 47.0 48.6 50.2 51.8 53.5 55.1 56.7 58.3 59.9 61.6 63.2 64.8 66.4 68.0 69.7 71.3 72.9 74.5 76.1 77.8 79.4 81.0
32.4 34.0 35.6 37.3 38.9 40.5 42.1 43.7 45.4 47.0 48.6 50.2 50.0 50.0 50.0 50.0 50.0 50.0 50.0 50.0 50.0 50.0 50.0 50.0 50.0 50.0 50.0 50.0 50.0 50.0 50.0
N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A 1.8 3.5 5.1 6.7 8.3 9.9 11.6 13.2 14.8 16.4 18.0 19.7 21.3 22.9 24.5 26.1 27.8 29.4 31.0
32.4 34.0 35.6 37.3 38.9 40.5 42.1 43.7 45.4 47.0 48.6 50.2 51.8 53.5 55.1 56.7 58.3 59.9 61.6 63.2 64.8 66.4 68.0 69.7 71.3 72.9 74.5 76.1 77.8 79.4 81.0
* Infusion rate is the same for both the first and second syringes.
The above table has been checked by the Pharmacy Department and ratified as correct.
To ensure that every effort can be made to prevent serious bleeding or other complications IM injections can cause bleeding at the injection site in patients who have received thrombolytic therapy Anticoagulants are contraindicated in patients who have received thrombolysis due to the increased risk of bleeding
Should haemorrhage be diagnosed please send samples for urgent FBC, clotting screen and These results can enable an abnormality to be Group & Save detected and early treatment initiated Refer to the appropriate protocol for extracranial or intracranial haemorrhage
Adapted from Lothian University Hospitals NHS Trust Nursing Protocol for the IST-3 trial
THROMBOLYSIS FOR ACUTE ISCHAEMIC STROKE NURSING PROTOCOL ACTION RATIONALE Blood pressure is to be maintained between 110/60 and 240/120mmHg If BP outside these parameters call the appropriate doctor. Signs of raised intracranial pressure or intracranial bleeding: unequal pupils sudden drop in GCS onset of drowsiness onset of nausea, vomiting, sometimes photophobia Rising BP and falling pulse To maintain adequate cerebral perfusion pressure to perfuse the brain, but reduce the risk of intracerebral bleeding due to hypertension
To diagnose if there has been a further intracranial event and seek urgent assistance
Early detection and intervention can minimise In the event of a sudden drop in GCS or change complications. An urgent CT scan can be in vital signs an urgent medical review is arranged to help detect complications of essential. treatment If temperature is elevated above 370C, treat with PR or PO paracetamol 1g 4 hourly. Report any sustained pyrexia Consider an anaphylactoid reaction if the patient develops rash, urticaria, bronchospasm, angioedema, and hypotension Stop rt-PA infusion obtain immediate medical assistance Ensure thrombolytic drug is prescribed on drug chart Increased temperature is detrimental to recovery in patients who have suffered brain attacks
According to NHS Forth Valley policy all drugs should be prescribed Early intervention can limit complications
Adapted from Lothian University Hospitals NHS Trust Nursing Protocol for the IST-3 trial
On arrival of patient
Record basic observations on chart GCS Pulse Blood pressure O2 saturation
Thrombolytic Therapy
Where thrombolytic therapy has not been given: Initial bolus of thrombolytic to be given over 1-2 minutes by doctor Remainder of treatment to be given over 1 hour via syringe driver
IF THERE ARE ANY SIGNS OF BLEEDING OR THE PATIENT DETERIORATES IN ANY WAY, IMMEDIATELY CONTACT THE RESPONSIBLE MEDICAL TEAM Post treatment interventions
In the 24 hours post treatment avoid the following to minimise the risk of haemorrhage: Urinary catheterisation Nasogastric tube Central venous cannulation Arterial puncture The procedures may be necessary but should be discussed with medical team Avoid intra-muscular injections for 48 hours Avoid anticoagulant therapy Do not give aspirin until post-treatment CT results available Consider paracetamol for pyrexia
Unless there are problems which require emergency brain imaging (see below), a CT brain scan should be requested the day after treatment. This would normally be during working hours at a time most approximate to 24 hours post-treatment.
If progress is uncomplicated, patient will likely be ready to step down to ward-level care after 24 hours
Appropriately selected patients are more likely to benefit from thrombolysis than to come to harm
HROMBOLYSIS FOR ACUTE ISCHAEMIC STROKE NURSING SUMMARY THROMBOLYSIS FOR ACUTE ISCHAEMIC STROKE NURSING SUMMARY Potential Complication Extracranial Haemorrhage
Potential bleeding sites include (list not exhaustive): Arterial & venous puncture sites GI tract Urinary tract Retroperitoneum Occult injuries sustained if fell/collapsed at onset of stroke Suspect if Clinical signs of hypovolaemic shock tachycardia, fall in blood pressure, peripheral shutdown Evidence of blood loss such as melaena or haematuria Stop rt-PA infusion immediately Use mechanical compression to control bleeding if possible Check coagulation screen (PT, APTT, fibrinogen) and full blood count Send blood for Group & Save or cross-match depending on the situation Support circulation with intravenous fluids or blood transfusion as appropriate Discuss case & test results with haematologist Transfusion of fresh frozen plasma, cryoprecipitate and platelets may be necessary, depending on result of coagulation screen and advice of haematologist For severe life-threatening haemorrhage, a fibrinolytic inhibitor should be given immediately e.g. tranexamic acid 1g IV over 15 minutes repeated every 8 hours as necessary1 Delay any surgery until the fibrinolytic state is corrected
see appropriate protocol see appropriate protocol
Stop rt-PA infusion immediately Arrange an urgent CT brain scan Check coagulation screen (PT, APTT, fibrinogen) and full blood count Send blood for Group & Save Support circulation with intravenous fluids if necessary Discuss case & test results with haematologist Correct fibrinolytic state as advised If intracranial bleeding confirmed, discuss possibility of evacuating haematoma with neurosurgeons at Western General Hospital, Edinburgh If no intracranial haemorrhage is found on CT (or insufficient to explain symptoms), look for other causes of the deterioration
see appropriate protocol
Bronchospasm Shock
Stop rt-PA infusion Urgent medical assessment Airway, Breathing, Circulation, Disability, Exposure High flow oxygen Adrenaline 1:1000 solution 0.5ml IM (repeat if necessary) Antihistamine Chlorphenamine 10-20mg IV slowly Hydrocortisone 100-200mg IV slowly, IV Fluid challenge, Salbutamol nebs
Standard Management
Stop rt-PA infusion immediately Arrange an urgent CT brain scan Check coagulation screen (PT, APTT, fibrinogen) and full blood count Send blood for Group & Save Support circulation with intravenous fluids if necessary Discuss case & test results with haematologist Correct fibrinolytic state as advised If intracranial bleeding confirmed, discuss possibility of evacuating haematoma with neurosurgeons at Western General Hospital, Edinburgh If no intracranial haemorrhage is found on CT (or insufficient to explain symptoms), look for other causes of the deterioration Blood products are supplied by the Blood Transfusion laboratory once sanctioned by a haematologist. Tranexamic acid is stored in cupboards in the Emergency Department, Critical Care Unit, theatres, ward 6, ward 7 & the emergency drug cupboard in FVRH
Other Information
The manufacturers of rt-PA, Boehringer Ingelheim1 suggest that in potentially dangerous haemorrhage, in particular cerebral haemorrhage, the fibrinolytic therapy must be discontinued. Their advice is that most patients can then be managed with volume replacement. It is rarely necessary to replace the clotting factors because of the short half-life of the drug and the minimal effect on the systemic coagulation factors. In those who fail to respond, transfusion of cryoprecipitate, fresh frozen plasma and platelets should be considered: seek the advice of your local haematologist. Antifibrinolytics (e.g. tranexamic acid) are sometimes used, but the benefits are unclear. Clozel et al2 looked into the use of aprotinin as an antidote for rt-PA. In their small animal study they found that aprotinin immediately stopped thrombolysis, but the duration of this effect was dose dependent. However, this is now an unlicensed use for aprotinin and it is not stocked in Forth Valley. A study looking into intracranial haemorrhage after coronary thrombolysis3 found that the exact mechanisms behind the haemorrhage were unclear. Their patients had received rt-PA and heparin and it was suggested that excessive prolongation of the APTT and elevated fibrin degradation products may have contributed to the occurrence of intracranial haemorrhage. Hypofibrinogenemia was not a uniform finding. The British Society of Haematology produced a consensus report in 1995 on guidelines for the use of thrombolysis. For severe life threatening bleeding they suggest a fibrinolytic inhibitor such as aprotinin (see above) or tranexamic acid and replacement of clotting factors depending upon the results of a coagulation screen.4
References
1. Boehringer Ingelheim. Summary of product characteristics for Alteplase 2. Clozel JP, Banken L, Roux S. Aprotinin: an antidote for recombinant tissue-type plasminogen activator (rt-PA) active in vivo. J Am Coll Cardiol. 1990 Aug;16(2):507-10. 3. Kase CS, Pessin MS, Zivin JA et al. Intracranial haemorrhage after coronary thrombolysis with tissue plasminogen activator. Am J Med. 1992 Apr;92(4):384-90 4. Ludlam CA, Bennet B, Fox KAA, Lowe GDO, Reid AW. Guidelines for the use of thrombolytic therapy. Blood Coagulation and Fibrinolysis. 1995;6:273-285
Standard Management
Stop rt-PA infusion immediately Use mechanical compression to control bleeding if possible Check coagulation screen (PT, APTT, fibrinogen) and full blood count Send blood for Group & Save or cross-match depending on the situation Support circulation with intravenous fluids or blood transfusion as appropriate Discuss case & test results with haematologist Transfusion of fresh frozen plasma, cryoprecipitate and platelets may be necessary, depending on result of coagulation screen and advice of haematologist For severe life-threatening haemorrhage, a fibrinolytic inhibitor should be given immediately e.g. tranexamic acid 1g IV over 15 minutes repeated every 8 hours as necessary1 Delay any surgery until the fibrinolytic state is corrected Blood products are supplied by the Blood Transfusion laboratory once sanctioned by a haematologist. Tranexamic acid is stored in drug cupboards in the Emergency Department, Critical Care Unit, theatres, ward 6, ward 7 & the emergency drug cupboard in FVRH.
Other Information
Major bleeding is an infrequent but important complication of giving thrombolysis for acute ischaemic stroke. There are no definitive guidelines on the management of thrombolysis related bleeding, but the following points are a guide to managing such a patient in a safe and appropriate way. The manufacturer, Boehringer Ingelheim2 suggest that in potentially dangerous extracranial haemorrhage, the fibrinolytic therapy must be discontinued. Their advice is that most patients can then be managed with volume replacement. It is rarely necessary to replace the clotting factors because of the short half-life of the drug and the minimal effect on the systemic coagulation factors. In those who fail to respond, transfusion of cryoprecipitate, fresh frozen plasma and platelets should be considered. Antifibrinolytics can be used, but the benefits are unclear. Clozel et al3 looked into the use of aprotinin as an antidote for rt-PA. In their small animal study they found that aprotinin immediately stopped thrombolysis, but the duration of this effect was dose dependent. However, this is now an unlicensed use for aprotinin and it is not stocked in Forth Valley. A study looking into intracranial haemorrhage after coronary thrombolysis4 found that the exact mechanisms behind the haemorrhage were unclear. Their patients had received rt-PA and heparin and it was suggested that excessive prolongation of the APTT and elevated fibrin degradation products may have contributed to the occurrence of intracranial haemorrhage. Hypofibrinogenemia was not a uniform finding. The British Society of Haematology produced a consensus report in 1995 on guidelines for the use of thrombolysis. For severe life threatening bleeding they suggest a fibrinolytic inhibitor such as aprotinin (see above) or tranexamic acid and replacement of clotting factors depending upon the results of a coagulation screen.2
References
1. 2. 3. Ludlam CA, Bennet B, Fox KAA, Lowe GDO, Reid AW. Guidelines for the use of thrombolytic therapy. Blood Coagulation and Fibrinolysis. 1995;6:273-285 Boehringer Ingelheim. Summary of product characteristics for Alteplase Clozel JP, Banken L, Roux S. Aprotinin: an antidote for recombinant tissue-type plasminogen activator (rt-PA) active in vivo. J Am Coll Cardiol. 1990 Aug;16(2):507-10. Kase CS, Pessin MS, Zivin JA et al. Intracranial haemorrhage after coronary thrombolysis with tissue plasminogen activator. Am J Med. 1992 Apr;92(4):384-90
4.
Airway, Breathing, Circulation, Disability, Exposure Diagnosis - look for: 60 East Acute onset of illness West 1 Life-threatening Airway40 and/or Breathing and/or Circulation problems North Any usually skin changes
20 0 1st Qtr 2nd Qtr for 3rd Qtr 4th Qtr Lie patient flat. Call Help
2. Risk from anaphylaxis outweighs risk of haemorrhage from IM injection. Therefore give adrenaline as per usual protocol
IN ADDITION
For all severe or recurrent reactions and patients with asthma give HYDROCORTISONE 200mg slow IV
Nebulised SALBUTAMOL may be used as an adjunctive measure if bronchospasm is severe and does not respond to other treatment
1. Life Threatening Problems Swelling, Hoarseness, Stridor Rapid breathing, wheeze, fatigue, cyanosis, SpO2 < 92%, confusion Pale, clammy, low blood pressure, faintness, drowsy/coma
Page 1 of 2
Treatment:
If ANY features of angioedema occur STOP THE INFUSION IMMEDIATLEY (if not already completed). If not already in attendance, fast-page on-call MEDICAL MIDDLE GRADE Contact on-call ANAESTHETIST Commence treatment for anaphylaxis as above o High Flow oxygen o Chlorphenamine 10mg IV o Hydrocortisone 200mg IV Consider NEBULISED ADRENALINE (5ml of 1:1000 solution driven by 100% oxygen) o ENSURE EYE PROTECTION with goggles/wet swabs or paper towels o Can be repeated 2-3 hourly as required If no response to nebulised adrenaline within 5 minutes then give IM ADRENALINE 500micrograms (0.5ml of 1:1000 solution) o Risks associated with anaphylaxis outweigh the risks of haemorrhage related to IM injection during or after thrombolytic therapy Advanced airway management may be necessary if airway is significantly compromised, although there are specific risks associated with stroke and thrombolytic therapy o Airway haemorrhage due to trauma from intubation and thrombolysis o A drop in blood pressure due to rapid sequence induction may reduce cerebral perfusion pressure and increase the volume of ischaemic brain However, hypoxia due to airway compromise/loss will increase the risk of poor outcome Ongoing treatment o Once stabilised transfer to HDU or ITU as appropriate (following stroke thrombolysis the patient will normally be treated in HDU for first 24 hours). o Chlorphenamine 10mg IV tds o Hydrocortisone 100mg IV tds o Nebulised Adrenaline as required
1. 2. 3.
Hill MD, et al. Hemi-orolingual angioedema and ACE inhibition after alteplase treatment of stroke. Neurology 2003; 60: 1525-1527 Hill MD, et al for the Canadian Alteplase for Stroke Effectiveness Study (CASES) Investigators. Thrombolysis for acute ischemic stroke: results of the Canadian Alteplase for Stroke Effectiveness Study. Canadian Medical Association Journal 2005; 172:1307-1312 Engelter ST, et al. Life threatening orolingual angioedema during thrombolysis in acute ischemic stroke. Journal of Neurology 2005; 252:1167-1170
Page 2 of 2
Standard
Standard Treatment Dependent 41%
Clot-Buster
Clot-Busting Treatment Dependent 32%
Dead 18%
Dead 18%
Independent 41%
Independent 50%
Above graphs are for treatment started within 3 hours of the start of stroke symptoms
A patient has a 1 in 10 greater chance of living independently after treatment with the clot busting drug. (50% compared to 41%) There is a higher chance of bleeding into the brain (1 in 20 with clot-busting compared to 1 in 100 without) or bleeding elsewhere immediately after the injection and a small risk of allergic reaction.
1 in 10 greater chance of independence (being able to carry out all But, overall, patients are more likely to benefit from Alteplase than come previous activities, or with only a slight disability), and to harm. 1 in 10 reduced risk of being dependent (requiring help to walk or needing help with most bodily needs).
Publications in Alternative Formats NHS Forth Valley is happy to consider requests for publications in other language or formats such as large print. To request another language for a patient, please contact 01786 434784. For other formats contact 01324 590886, text 07990 690605, fax 01324 590867 or e-mail - fv-uhb.nhsfv-alternativeformats@nhs.net