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Goldman2015 PDF
Goldman2015 PDF
185
186 M. Goldman et al.
from Canada (M Goldman, P Robillard), the USA (K Land, P scheme and its related software, Donor-HART (Donor Hae-
Tomasulo) and Europe (J Wiersum-Osselton), some of movigilance Analysis and Reporting Tool) [3, 5].
whom were also part of the AABB Donor Hemovigilance There was substantial overlap between the two sys-
Working Group and the IHN. Classification schemes and tems. In the local symptoms category, the major differ-
definitions used in various jurisdictions were compared. A ence was in the categorization of pain syndromes. The
gap analysis was performed comparing the ISBT classifica- 2008 ISBT classification included three different cate-
tion scheme and AABB Haemovigilance classification gories, injury of a nerve by a haematoma, injury of a
Definition
A. Local Symptoms
A1 Blood outside vessel
Haematoma (bruise) Accumulation of blood in tissues
Arterial puncture Puncture of brachial artery or brachial artery branch
Delayed bleeding Rebleeding after initial bleeding has stopped
A2 Arm pain
Nerve injury/irritation Injury or irritation of a nerve
Duration < or > 12 months
Other arm pain Pain without characteristics of nerve irritation, large haematoma, or other possibly painful complications
A3 Localized infection/inflammation of vein or soft tissue
Localized infection/inflammation Inflammation along the course of a vein, which may progress to localized infection; there may be clotting
Optional split into 2 categories:
Thrombophlebitis Redness, swelling, tenderness extend along the vein
Cellulitis Redness, swelling, tenderness not localized to the vein
A4 Other major blood vessel injury – must be medically diagnosed
Deep Venous Thrombosis Thrombosis of a deep vein in phlebotomy arm
Arteriovenous fistula Acquired connection between vein and artery
Compartment syndrome Increased intracompartment pressure leading to necrosis
Brachial artery pseudoaneurysm Collection of blood outside an artery, contained by adventitia or the surrounding tissues alone
B. Generalized symptoms – vasovagal reactions
General feeling of discomfort and weakness with anxiety, dizziness and nausea, which may progress to loss of consciousness (faint)
No loss of consciousness The donor does not faint
Loss of consciousness The donor faints for a period of time
>60 sec, and/or complications
<60 sec, without complications
With or without injury Injury caused by falls or accidents
On or off collection site Before or after donor has left donation site
C. Related to apheresis
Citrate reactions Neuromuscular hyperactivity related to reduced Ca2+
Haemolysis Damaged donor red cells, releasing haemoglobin
Air embolism Air bubble introduced into the donor’s circulation
Infiltrationa Intravenous solute (saline solution) enters tissues
D. Allergic reactions
Local Red or irritated skin at the venipuncture site
Generalized (anaphylactic) Anaphylactic reactions may begin soon after starting the procedure, progress rapidly to cardiac arrest
E. Other serious complications – must be medically diagnosed, imputability assessedb
F. Other
Major cardiovascular event MIc, cardiac arrest, other acute cardiac symptoms, TIAd, CVAe, or death within 24 hours
after donation
a
When return fluid consisting of red cells in plasma and citrate goes extravascular, report under A1 Haematoma.
b
Only cases with definite, probable, or possible imputability included for international reporting.
c
MI: myocardial infarction.
d
TIA: transient ischaemic attack.
e
CVA: cerebrovascular accident.
nerve and tendon injury, as well as a category of painful collection. The opposing goals of simplicity and ease of
arm where no further details allowed subspecification. use and granularity to permit further analysis were in
The AABB classification included one category, nerve part handled by having mandatory broad categories with
injury/irritation. In the systemic symptoms category, the optional subcategories.
major difference was in the categorization of vasovagal A draft version of the revised standard was circulated
reactions. In the 2008 ISBT classification, the differentia- to members of the ISBT and AABB Donor Haemovigilance
tion between mild reactions and moderate reactions was Working Groups and other industry groups such as the
the absence or presence of objective symptoms (changes ABO medical group and the EBA. Comments were
in pulse and/or blood pressure or loss of consciousness); obtained from over 10 blood establishments and resulted
severe reactions were characterized by hospitalization or in further changes or explanatory comments regarding
significant incapacity. The AABB haemovigilance defini- the proposed classification scheme and denominator data.
tions and Donor-HART capture actual symptoms to
describe what is happening in a descriptive way without
Results
necessarily grouping symptoms into categories [3]. For
example, there is a list of 12 symptoms and signs that The revised classification scheme and abbreviated defini-
can be entered related to prefaint vasovagal reactions. tions are shown in Table 1. The recommended numerator
The presence and duration of loss of consciousness sepa- and denominator parameters and basic information about
rated mild, moderate and severe reactions. Injury was donor screening and collection practices are shown in
considered a separate attribute. Table 2. Optional categories are shown in italics. The
The 2008 ISBT classification scheme did not mention mechanisms and signs and symptoms of each reaction, as
what specific parameters, such as donor age and gender, well as a data entry form, are included on the ISBT Web-
should be included both for donors experiencing a reac- site [5]. Adjustments were made to the AABB Haemovigi-
tion, and for the total donor population. This information lance definitions to easily align with the revised
is necessary for understanding the incidence of reactions classification system. Additionally, the Donor-HART soft-
in different groups, and for performing risk factor analy- ware was modified to more easily accommodate simpler
sis [2, 6, 7]. The AABB Donor-HART system permits the surveillance definitions and entry of a minimal amount
entry of many denominator dimensions. For example, of aggregate denominator data.
donors are split into nine different age groups and 15 dif- In December 2014, the revised definitions and recom-
ferent weight categories. This granularity may be valuable mended parameters to be recorded were published online
for individual blood establishments and provide data for with joint authorship and ownership of the ISBT, the
hypothesis generation about reaction mechanisms and IHN and the AABB, and formal endorsement by the EBA
risk factors [7]. However, it is beyond what many blood and the ABO. Other international organizations, includ-
establishments capture routinely and may add a heavy ing the WHO and the Council of Europe, have also been
data entry burden for establishments using manual data notified.
References
1 Eder AF: Improving safety for young programs/biovigilance [last accessed 15 on definitions) [last accessed 15 April
blood donors. Transfus Med Rev 2012; April 2015] 2015]
26:14–26 4 Katz L, Benjamin RJ, Tomasulo PA, 6 Goldman M, Osmond L, Yi Q-L, et al.:
2 Eder AF, Dy BA, Kennedy JM, et al.: et al.: Interventions for Vasovagal Frequency and risk factors for donor
Improved safety for young whole blood Reactions (VVRs) at Alliance of Blood reactions in an anonymous blood donor
donors with new selection criteria for Operator (ABO) Blood Establishments survey. Transfusion 2013; 53:1979–
total estimated blood volume. Transfu- (BEs): An International Survey for the 1984
sion 2011; 51:1522–1531 ABO Medical Working Group. Transfu- 7 Bravo M, Kamel H, Custer B, et al.: Fac-
3 American Association of Blood Banks. sion 2014; 54(Suppl):110A tors associated with fainting – before,
Biovigilance. 2012. [cited 2015 Mar 17]. 5 ISBT website: http://www.isbtweb.org/ during and after whole blood donation.
Available from: http://www.aabb/org/ working-parties/haemovigilance/ (click Vox Sang 2011; 101:303–312