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The safety of COVID-19 convalescent plasma donation: A multi-institutional donor hemovigilance study
Joseph H Cho1, Srijana Rajbhandary2, Nancy L van Buren3
1Medical Sciences Institute, Versiti, Milwaukee, Wisconsin, USA.
Insights
COVID-19 convalescent plasma (CCP) donation safety was assessed across nine institutions. Donor adverse events were comparable to conventional apheresis, with vasovagal reactions being most common.
Area of Science:
- Transfusion Medicine
- Hematology
- Immunology
Background:
- The safety of COVID-19 convalescent plasma (CCP) for patients is known, but donor safety during CCP donation requires further investigation.
- Multi-institutional data on CCP donor safety is limited.
Purpose of the Study:
- To evaluate the safety of COVID-19 convalescent plasma donation.
- To identify risk factors associated with donor adverse events (DAEs) during CCP donation.
Main Methods:
- A multi-institutional hemovigilance study involving nine blood collection organizations (BCOs).
- Standardized definitions for donor adverse events (DAEs) and severity grading were used.
- Multivariate analysis to identify factors associated with DAE severity.
Main Results:
- The overall DAE rate was 37.7 per 1000 donations.
- Vasovagal reactions constituted over half of all DAEs (51.1%).
- Higher CCP volume, female donor sex, and apheresis-naïve status were associated with increased DAE risk and severity.
Conclusions:
- COVID-19 convalescent plasma donation safety is comparable to conventional apheresis plasma donation.
- Identified risk factors for DAEs in CCP donors align with those in general apheresis donors.
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.
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