Hemovigilance is the systematic monitoring of adverse reactions and incidents in the transfusion chain in order to make recommendations for safety improvement. EU member states must have a... Show moreHemovigilance is the systematic monitoring of adverse reactions and incidents in the transfusion chain in order to make recommendations for safety improvement. EU member states must have a reporting system for serious adverse reactions or events which might have an effect on quality or safety of blood components. The thesis presents an analysis of routinely collected data on occurrence of blood donation complications and risk factors. A study of procedural and follow-up data from a cohort of related peripheral blood stem cell donors gave no indication of unacceptable risks. In transfused patients an exploratory case-control study found previously undescribed associations with patient characteristics. Using national hemovigilance data the reduction of the risk of TRALI following implementation of male-only plasma was estimated as 33%. Hospitals with a relatively high rate of reported nonserious transfusion reactions were also more likely to have reported one or more transfusion errors, thus this does not support the notion that they might be safer. Hemovigilance reporting has provided insight in short-term risks in the transfusion chain. Additonal methods should be sought for monitoring long-term risks and for promoting measures to bring about safety improvement. Show less
Middelburg, R.A.; Beckers, E.A.M.; Porcelijn, L.; Lardy, N.; Wiersum-Osselton, J.C.; Schipperus, M.R.; ... ; Bom, J.G. van der 2012
Transfusion-related acute lung injury (TRALI) is the most common serious side effect of blood transfusion. TRALI could be caused by donor leukocyte antibodies, present primarily in female and... Show moreTransfusion-related acute lung injury (TRALI) is the most common serious side effect of blood transfusion. TRALI could be caused by donor leukocyte antibodies, present primarily in female and transfused donors (Chapters 1 and 2). In The Netherlands this led to the exclusion of female and transfused donors from the donation of plasma for transfusion from 1st October 2006. In this thesis we aimed to quantitatively estimate the expected effect of the implementation of this measure. Chapters 5 through 7 suggest nearly all TRALI caused by plasma rich products to be preventable by the deferral of female or allo-exposed donors, while there is no such effect on TRALI caused by plasma poor products. Further, we evaluate the effectiveness of the plasma measure and other potential donor deferral strategies at keeping leukocyte antibodies out of the blood supply (Chapter 8), address several common methodological problems in research of side effects of blood transfusions (Chapters 3 and 4) and discuss all our findings and some more general issues concerning the use of the population attributable risk, as opposed to the relative risk, and correction of the population attributable risk for confounding (Chapter 9). Show less
