PMID- 28626370
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20201001
IS  - 1660-3796 (Print)
IS  - 1660-3818 (Electronic)
IS  - 1660-3796 (Linking)
VI  - 44
IP  - 3
DP  - 2017 Jun
TI  - Donor Safety in Haemapheresis: Development of an Internet-Based Registry for 
      Comprehensive Assessment of Adverse Events from Healthy Donors.
PG  - 188-200
LID - 10.1159/000452107 [doi]
AB  - 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 Hamapheresevigilanz; 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.
FAU - Heuft, Hans-Gert
AU  - Heuft HG
AD  - Institute for Transfusion Medicine, Hanover Medical School, Hanover, Germany.
FAU - Fischer, Eike
AU  - Fischer E
AD  - Aix-Scientifics(R), Clinical Research Organisation, Aachen, Germany.
FAU - Weingand, Tina
AU  - Weingand T
AD  - Blood Donation Service, Swiss Red Cross, Luzern, Switzerland.
FAU - Burkhardt, Thomas
AU  - Burkhardt T
AD  - German Red Cross Blood Donation Service North-East, Plauen, Germany.
FAU - Leitner, Gerda
AU  - Leitner G
AD  - University Clinic for Blood Group Serology and Transfusion Medicine, Vienna, 
      Austria.
FAU - Baume, Hagen
AU  - Baume H
AD  - German Red Cross Donation Service NSTOB, Institute Oldenburg, Oldenburg, Germany.
FAU - Schmidt, Jorg-Peter
AU  - Schmidt JP
AD  - German Red Cross Blood Donation Service NSTOB, Institute Dessau, Dessau, Germany.
FAU - Buser, Andreas
AU  - Buser A
AD  - University Blood Donation Service Basel, Basel, Switzerland.
FAU - Fauchald, Gabriele
AU  - Fauchald G
AD  - Bavarian Red Cross, Munich, Germany.
FAU - Reinicke Voigt, Ute
AU  - Reinicke Voigt U
AD  - Institute for Transfusion Medicine, University Clinic Munster, Munster, Germany.
FAU - Mansouri-Taleghani, Behrouz
AU  - Mansouri-Taleghani B
AD  - Medical Directorate of the Swiss Red Cross, Bern, Switzerland.
LA  - eng
PT  - Journal Article
DEP - 20161128
PL  - Switzerland
TA  - Transfus Med Hemother
JT  - Transfusion medicine and hemotherapy : offizielles Organ der Deutschen 
      Gesellschaft fur Transfusionsmedizin und Immunhamatologie
JID - 101176417
PMC - PMC5473082
OTO - NOTNLM
OT  - Adverse events
OT  - Adverse reactions
OT  - Donor safety
OT  - Haemapheresis
OT  - Haemovigilance
OT  - Plasmapheresis
OT  - Plateletpheresis
OT  - Stem cell collection
EDAT- 2017/06/20 06:00
MHDA- 2017/06/20 06:01
PMCR- 2016/11/28
CRDT- 2017/06/20 06:00
PHST- 2016/07/19 00:00 [received]
PHST- 2016/09/25 00:00 [accepted]
PHST- 2017/06/20 06:00 [entrez]
PHST- 2017/06/20 06:00 [pubmed]
PHST- 2017/06/20 06:01 [medline]
PHST- 2016/11/28 00:00 [pmc-release]
AID - tmh-0044-0188 [pii]
AID - 10.1159/000452107 [doi]
PST - ppublish
SO  - Transfus Med Hemother. 2017 Jun;44(3):188-200. doi: 10.1159/000452107. Epub 2016 
      Nov 28.