Orru' Stefano, Poetzsch Kay, Hoffelner Marcus, Heiden Margarethe, Funk Markus B, Keller-Stanislawski Brigitte, Oberle Doris
Safety of Medicinal Products and Medical Devices Division, Paul-Ehrlich-Institut, Langen, Germany.
Transfus Med Hemother. 2021 Mar 31;48(5):272-283. doi: 10.1159/000516049. eCollection 2021 Oct.
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.
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.
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).
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.
根据德国法律，保罗·埃利希研究所一直在持续评估与献血及其成分相关的疑似严重不良反应（AR）报告。本次调查旨在更全面地了解与献血和血液成分相关的不良反应。
符合条件的献血者有机会通过填写在线问卷，匿名报告其上次献血期间或之后发生的所有不良反应。报告的不良反应根据《献血相关并发症监测标准》进行分类。将献血者对不良反应严重程度的自我评估与德国法律规定的官方严重程度分类进行比较。除了描述性统计分析外，还进行了多元逻辑分析以确定不良反应的风险因素。
共评估了8138条数据记录。参与调查的男性略多（57.9%），除了60岁及以上的献血者外，各年龄组的代表性相当。大多数参与者是全血献血者（85.4%）、重复献血者（97.2%），并且在献血后在采血机构（BE）停留观察超过5分钟（63.1%）。大多数参与者未报告任何反应（72.5%），而2237人报告了至少一种不良反应（27.5%），其中475人接受了单采，1762人捐献了全血。大多数不良反应发生在离开采血机构之后（64.4%）。只有少数参与者需要医疗治疗（5.1%）或将经历的不良反应评估为严重（3.9%）。报告最频繁的献血者不良反应是血肿和其他局部反应（57.6%）。分别有17%和2%的参与者发生了无晕厥和有晕厥的血管迷走神经反应，而7.6%的人经历了枸橼酸盐反应。也报告了新的不良反应（即过敏反应和与缺铁相关的症状）。不良反应的发生与风险因素有关（即女性、年轻、首次献血和血小板单采）。
本次调查产生了更全面的不良反应谱，揭示了症状出现的时间延长，并确定了不良反应的风险因素。这些新信息可用于修订后的知情同意书中，以说明常见和罕见的不良反应。
