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Abstract/Summary
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INTRODUCTION: According to German legislation, reports of suspected serious adverse reactions (AR) associated with the donation of blood and its components are continuously being evaluated by the Paul-Ehrlich-Institut. This survey aimed at providing a more complete picture of the AR associated with the donation of blood and blood components. MATERIALS AND METHODS: Eligible donors had the opportunity to anonymously report all AR occurring during or after their last donation by completing an online questionnaire. Reported AR were classified according to the Standard for Surveillance of Complications Related to Blood Donation. Donors’ self-assessment of AR seriousness was compared with the official severity classification as laid down by German legislation. Besides a descriptive statistical analysis, a multiple logistic analysis was performed to identify risk factors for AR. RESULTS: A total of 8,138 data records were evaluated. Slightly more males (57.9%) participated in the survey and, except for donors aged ≥60 years, all age groups were equally represented. The majority of participants were whole blood donors (85.4%), repeat donors (97.2%), and stayed under observation in the blood establishment (BE) for more than 5 min (63.1%) after donation. Most participants did not report any reaction (72.5%), whereas 2,237 reported at least one AR (27.5%), 475 of whom underwent apheresis and 1,762 donated whole blood. Most AR occurred after leaving the BE (64.4%). Only a minority of participants required medical treatment (5.1%) or assessed the experienced AR as serious (3.9%). The most frequently reported donor AR were haematoma and other local reactions (57.6%). Vasovagal reactions without and with loss of consciousness were developed in 17 and 2% of the participants, respectively, whilst 7.6% experienced citrate reactions. New AR (i.e., allergic reactions and symptoms associated with iron deficiency) were reported as well. The occurrence of AR was linked to risk factors (i.e., female gender, young age, first-time donation, and thrombocytapheresis). DISCUSSION: This survey yielded a more comprehensive AR spectrum, revealed a prolonged time to symptom onset, and identified risk factors for AR. This novel information could be implemented in an amended informed consent addressing common and rare AR.
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