July 07, 2021
The safety of COVID-19 convalescent plasma (CCP) donation appears comparable to that of conventional apheresis plasma donation, according to findings from a hemovigilance analysis published this week in Transfusion. A sub-group of the AABB Donor Hemovigilance Working Group analyzed data from nine blood collection organizations to assess the safety of apheresis CCP donation; whole blood CCP donors were not included.
Data indicated that the rate of donor adverse events (DAE) associated with CCP donation appears to fall within the reported range for conventional apheresis plasma donation, although investigators did not perform a direct statistical comparison against the comparator apheresis data (DonorHART). The overall DAE rate for CCP donors was 37.7 per 1,000 donations, compared to 22.8 per 1,000 donations in DonorHART.
Repeat apheresis and apheresis-naïve donors experienced adverse event rates of 19.9 and 49.8 per 1,000 donations, respectively. Investigators noted that DonorHART data comprises 84% repeat donors, which further supports that the DAE rate for CCP donation, with a high percentage of first-time donors, is within the range of conventional apheresis plasma donation. Investigators also found that female donors had a DAE rate of 49.4 per 1,000 donations, while the DAE rate for male donors was 27.4 per 1,000 donations.
Vasovagal reactions accounted for more than half of all reported DAEs (51.1%). After adjustment, the volume of CCP donated was associated with more serious vasovagal reactions (odds ratio [OR] 6.5, Grade 2 and above compared to Grade 1 [DAE Severity Grading Tool]). Donor age and donation history were also associated with more serious DAE. The investigators observed considerable differences in DAE types and rates across participating blood collection organizations despite the use of standardized hemovigilance definitions. These variations, they concluded, illustrate the importance of standardized procedures for conducting collaborative donor hemovigilance studies.