The safety of COVID‐19 convalescent plasma donation: A multi‐institutional donor hemovigilance study

Abstract

Background: Although the safety and therapeutic efficacy of COVID-19 convalescent plasma (CCP) has been extensively evaluated, the safety of CCP donation has not been explored in a multi-institutional context.Study design and methods: Nine blood collection organizations (BCOs) participated in a multi-institutional donor hemovigilance effort to assess the safety of CCP donation. Donor adverse events (DAEs) were defined according to the Standard for Surveillance of Complications Related to Blood Donation, and severity was assessed using the severity grading tool. Multivariate analysis was performed to determine attributes associated with DAE severity. Results: The overall DAE rate was 37.7 per 1000 donations. Repeat apheresis and apheresis-naïve donors experienced adverse event rates of 19.9 and 49.8 per 1000 donations, respectively. Female donors contributed 51.9% of CCP donations with a DAE rate of 49.4 per 1000 donations. The DAE rate for male donors was 27.4 per 1000 donations. Vasovagal reactions accounted for over half of all reported DAEs (51.1%). After adjustment, volume of CCP donated was associated with vasovagal reaction severity (odds ratio [OR] 6.5, 95% confidence interval [CI] 2.5-17.1). Donor age and donation history were also associated with DAE severity. Considerable differences in DAE types and rates were observed across the participating BCOs despite the use of standardized hemovigilance definitions. Conclusion:The safety of CCP donation appears comparable to that of conventional apheresis plasma donation with similar associated risk factors for DAE types and severity.

The safety of plasma apheresis from donors recovering from COVID-19 infection in Japan

“…There are some limitations in this study. First, our sample size was small; therefore, the DAE incidence is difficult to generalize among other studies [6] , [7] , [8] investigating CCP donors. Second, the participants were not all volunteers in this study.…”

“…The DAEs were reported to be 7.96 % in first-time healthy donors compared with 1.01 % in repeat donors for plasmapheresis in the U.S. [7] . Another study reported that the incidence of DAEs in first-time CCP donors was 5.00–5.59 %, 1.79–2.50-fold higher than in repeat CCP donors [7] , [8] . We also analyzed the CCP collection incidence compared to previous reports in other countries ( Table 7 and Table 8 ) [6] , [7] .…”

“…Moreover, we compared CPP collection by donor attributions. The incidence of DAEs during CCP apheresis was significantly higher in donors who had severe disease than in healthy donors in Japan and the U.S., according to Donor HART™: 2014–2017 data, which reports the data of the healthy donors for plasma collection in the U.S. [8] (Table 9). No other details were available from the respective literature, but no significant differences were found concerning the main items.…”

“…Worldwide, a few studies have investigated the safety of apheresis using donors who have recovered from COVID-19. The total incidence of Donors Adverse Events (DAEs) was 2.58 % (n = 504) in an Italian study [6] , 13.7 % (n = 14,272) in a recent study by the American Red Cross [7] , and 3.77 % (n = 37,174) in a U.S. multicenter study [8] . Some studies also reported cardiovascular complications, such as arrhythmia [9] .…”

Development of the Chinese Haemovigilance Network and reporting of adverse transfusion reactions from 2018 to 2020

“…The analysis of ATRs in this study is useful and provides valuable information about the need for further training in ATR recognition. In addition, the outbreak of COVID‐19 pandemic has made us more aware of the importance of an all‐sided haemovigilance system, not only ATR but also the donor side, cell therapy and so on, for the comprehensive monitoring of the whole transfusion chain [29]. The donor side of CHN was established at the end of 2021, but more efforts are needed to develop CHN in the future.…”