Centre for Evidence-Based Practice, Belgian Red Cross, Mechelen, Belgium.
Department of Public Health and Primary Care, KU Leuven, Leuven, Belgium.
Vox Sang. 2024 Feb;119(2):110-120. doi: 10.1111/vox.13544. Epub 2023 Oct 10.
As part of a large-scale project to safely increase plasma collection in Europe, the current scoping review identifies the existing evidence (gaps) on adverse events (AEs) and other health effects in plasmapheresis donors, as well as factors that may be associated with such events/effects.
We searched six databases and three registries. Study characteristics (publication type, language, study design, population, outcomes, associated factors, time of assessment, duration of follow-up, number and frequency of donations, convalescent plasma [y/n], setting and location) were synthesized narratively and in an interactive evidence gap map (EGM).
Ninety-four research articles and five registrations were identified. Around 90% were observational studies (57 controlled and 33 uncontrolled), and most of them were performed in Europe (55%) or the United States (20%). Factors studied in association with donor health included donor characteristics (e.g., sex, age) (n = 27), cumulative number of donations (n = 21), donation frequency (n = 11), plasma collection device or programme (n = 11), donor status (first time vs. repeat) (n = 10), donation volume per session (n = 8), time in donation programme (n = 3), preventive measures (n = 2) or other (n = 9).
The current scoping review provides an accessible tool for researchers and policymakers to identify the available evidence (gaps) concerning plasmapheresis donation safety. Controlled prospective studies with long-term donor follow-up are scarce. Furthermore, additional experimental studies comparing the health effects of different donation frequencies are required to inform a safe upper limit for donation frequency.
作为一项旨在安全增加欧洲血浆采集规模的大型项目的一部分，本范围界定综述确定了关于血浆单采供体不良事件 (AE) 和其他健康影响的现有证据（差距），以及可能与这些事件/影响相关的因素。
我们搜索了六个数据库和三个登记处。研究特征（出版物类型、语言、研究设计、人群、结局、相关因素、评估时间、随访时间、捐献次数和频率、恢复期血浆 [y/n]、设置和地点）以叙述性和交互式证据差距图 (EGM) 进行综合。
确定了 94 篇研究文章和 5 个登记处。大约 90%是观察性研究（57 项对照和 33 项非对照），其中大部分在欧洲（55%）或美国（20%）进行。与供体健康相关的研究因素包括供体特征（如性别、年龄）（n=27）、累计捐献次数（n=21）、捐献频率（n=11）、血浆采集装置或方案（n=11）、供体状态（首次与重复）（n=10）、每次捐献的体积（n=8）、捐献计划时间（n=3）、预防措施（n=2）或其他（n=9）。
本范围界定综述为研究人员和决策者提供了一种易于使用的工具，可用于确定有关血浆单采捐献安全性的现有证据（差距）。长期随访供体的对照前瞻性研究很少。此外，需要比较不同捐献频率对健康影响的额外实验研究，以便为捐献频率的安全上限提供信息。
