PMID- 27658188 OWN - NLM STAT- MEDLINE DCOM- 20170116 LR - 20181202 IS - 1423-0410 (Electronic) IS - 0042-9007 (Linking) VI - 111 IP - 4 DP - 2016 Nov TI - The International Haemovigilance Network Database for the Surveillance of Adverse Reactions and Events in Donors and Recipients of Blood Components: technical issues and results. PG - 409-417 LID - 10.1111/vox.12447 [doi] AB - BACKGROUND AND OBJECTIVES: The International Haemovigilance Network's ISTARE is an online database for surveillance of all adverse reactions (ARs) and adverse events (AEs) associated with donation of blood and transfusion of blood components, irrespective of severity or the harm caused. ISTARE aims to unify the collection and sharing of information with a view to harmonizing best practices for haemovigilance systems around the world. MATERIALS AND METHODS: Adverse reactionss and adverse events are recorded by blood component, type of reaction, severity and imputability to transfusion, using internationally agreed standard definitions. RESULTS: From 2006 to 2012, 125 national sets of annual aggregated data were received from 25 countries, covering 132.8 million blood components issued. The incidence of all ARs was 77.5 per 100 000 components issued, of which 25% were severe (19.1 per 100 000). Of 349 deaths (0.26 per 100 000), 58% were due to the three ARs related to the respiratory system: transfusion-associated circulatory overload (TACO, 27%), transfusion-associated acute lung injury (TRALI, 19%) and transfusion-associated dyspnoea (TAD, 12%). Cumulatively, 594 477 donor complications were reported (rate 660 per 100 000), of which 2.9% were severe. CONCLUSIONS: ISTARE is a well-established surveillance tool offering important contributions to international efforts to maximize transfusion safety. CI - (c) 2016 International Society of Blood Transfusion. FAU - Politis, C AU - Politis C AD - Coordinating Haemovigilance Centre (SKAE), Hellenic Centre for Disease Control and Prevention, Athens, Greece. FAU - Wiersum, J C AU - Wiersum JC AD - TRIP National Hemovigilance and Biovigilance Office, Leiden, The Netherlands. FAU - Richardson, C AU - Richardson C AD - Panteion University of Social and Political Sciences, Athens, Greece. FAU - Robillard, P AU - Robillard P AD - Hema-Quebec, Montreal, QC, Canada. FAU - Jorgensen, J AU - Jorgensen J AD - Clinical Immunology, Aarhus University Hospital, Aarhus, Denmark. FAU - Renaudier, P AU - Renaudier P AD - Agence Regionale de Sante, Nancy, France. FAU - Faber, J-C AU - Faber JC AD - LuxConsulTrans(R), Banglamung, Thailand. FAU - Wood, E M AU - Wood EM AD - Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Vic., Australia. LA - eng PT - Journal Article DEP - 20160922 PL - England TA - Vox Sang JT - Vox sanguinis JID - 0413606 SB - IM MH - Acute Lung Injury/epidemiology/etiology MH - Blood Donors MH - *Blood Safety MH - Blood Transfusion/statistics & numerical data MH - Epidemiological Monitoring MH - Humans MH - *Transfusion Reaction OTO - NOTNLM OT - adverse events OT - adverse reactions OT - blood donation OT - blood transfusion OT - haemovigilance OT - transfusion errors EDAT- 2016/09/23 06:00 MHDA- 2017/01/17 06:00 CRDT- 2016/09/23 06:00 PHST- 2016/05/11 00:00 [received] PHST- 2016/08/03 00:00 [revised] PHST- 2016/08/09 00:00 [accepted] PHST- 2016/09/23 06:00 [pubmed] PHST- 2017/01/17 06:00 [medline] PHST- 2016/09/23 06:00 [entrez] AID - 10.1111/vox.12447 [doi] PST - ppublish SO - Vox Sang. 2016 Nov;111(4):409-417. doi: 10.1111/vox.12447. Epub 2016 Sep 22.