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2017 ; 44
(3
): 188-200
Nephropedia Template TP
gab.com Text
Twit Text FOAVip
Twit Text #
English Wikipedia
Donor Safety in Haemapheresis: Development of an Internet-Based Registry for
Comprehensive Assessment of Adverse Events from Healthy Donors
#MMPMID28626370
Heuft HG
; Fischer E
; Weingand T
; Burkhardt T
; Leitner G
; Baume H
; Schmidt JP
; Buser A
; Fauchald G
; Reinicke Voigt U
; Mansouri-Taleghani B
Transfus Med Hemother
2017[Jun]; 44
(3
): 188-200
PMID28626370
show ga
BACKGROUND: Currently, there is an extensive but highly inconsistent body of
literature regarding donor adverse events (AEs) in haemapheresis. As the reports
diverge with respect to types and grading of AEs, apheresis procedures and
machines, the range of haemapheresis-related AEs varies widely from about 0.03%
to 6.6%. METHODS: The German Society for Transfusion Medicine and
Immunohaematology (DGTI) formed a 'Haemapheresis Vigilance Working Party'
(Arbeitsgemeinschaft Hämapheresevigilanz; AGHV) to create an on-line registry for
comprehensive and comparable AE assessment with all available apheresis devices
in all types of preparative haemapheresis: plasmapheresis (PLS), plateletpheresis
(PLT), red blood cell apheresis, all kind of leukaphereses (autologous/allogeneic
blood stem cell apheresis, granulocyte apheresis, lymphocyte/monocyte apheresis)
and all possible types of multi-component apheresis. To ensure the comparability
of the data, the AGHV adopted the 'Standard for Surveillance of Complications
Related to Blood Donation' from the International Society for Blood Transfusion
in cooperation with the International Haemovigilance Network (IHN) and the
American Association of Blood Banks for AE acquisition and automated evaluation.
The registry is embedded in a prospective observational multi-centre study with a
study period of 7 years. RESULTS: A preliminary evaluation encompassed the time
period from January, 2012 to December, 2015. During this time, the system proved
to be safe and stable. Out of approximately 345,000 haemaphereses 16,477 AEs were
reported (4.9%) from 20 participating centres. The majority of AEs occurred in
PLSs (63%), followed by PLT (34.5%) and SC (2.2%). Blood access injuries (BAI)
accounted for about 55% of the supplied AEs, whereas citrate toxicity symptoms,
vasovagal reactions and technical events (e.g. disposable leakages, software
failures) rather equally affected haemaphereses at 8-15%. Out of 12,348 finalized
AEs, 8,759 (70.1%) were associated with a procedure-related break-off, with BAI
being the prevailing cause (5,463/8,759; 62.4%). An automated centre- and
procedure-specific AE evaluation according to the latest IHN standard and AGHV
pre-settings is available within a few minutes. CONCLUSIONS: An on-line
electronic platform for comprehensive assessment and centre-specific automated
evaluation of AEs in haemaphereses has been developed and proved to be stable and
safe over a period of 4 years.