Repeat donation and deferral rates in US source plasma donors: Exploratory analysis from the IMPACT trial

Abstract

Background The IMPACT trial demonstrated the safety of a new personalized nomogram for plasma donation and provided an opportunity to explore short‐ to mid‐term impact on repeat donation and deferral rates, and factors affecting these. Study Design and Methods In the IMPACT trial, participants were randomized to donate plasma using an established weight‐based nomogram (control) versus a new personalized nomogram incorporating height, weight, and hematocrit (experimental). In this exploratory analysis, repeat donations (per donor, by study arm) were analyzed using negative binomial generalized linear regression models and descriptive statistics. The mean number of donor deferral events was compared between the two arms using logistic regression and count data modeling approaches and were analyzed by lead cause. Results The predicted mean number of repeat donations was similar between the control and experimental arms (6.82 vs. 6.62, respectively; p = .22). Overall, the predicted mean number of repeat donations was significantly higher in males compared with females (p < .0001). Naïve donors had on average 2.8/2.7 (control/experimental) fewer repeat donations compared with experienced donors. In 23, 137 donations from 3443 donors, 798 donors (376 control, 422 experimental, p = .80) had at least one deferral (for any cause). The predicted mean number of deferrals in all categories of interest was not statistically different between the study arms. Conclusion Similar repeat donation and deferral rates between arms suggest that the new nomogram did not result in disruptions to subsequent donation. Further longitudinal research on mid‐ to long‐term effects is warranted.

Source plasma deferral trends: A 3‐year analysis of 255 centers in the United States

“…In one arm, donors donated plasma based upon a weight‐based nomogram, which is standard for SP donation, and in another arm, the donor height, weight, and hematocrit were used to determine a plasma donation volume. The number of repeat donations was essentially the same in both arms as was the number of deferrals 15 . There were 798 donors with at least one deferral in this study.…”

“…There were 798 donors with at least one deferral in this study. A total of 376 donors from the weight‐based arm were deferred as compared to 422 donors from the other arm 15 . Thus, there did not appear to be an increase in hypotensive DAEs.…”

“…By decreasing overall donor deferrals, more donors would be eligible to donate and less donors would be lost due to the deferral and dropping out of the program. Loss of donors due to deferrals, even short deferrals, can add up to a significant loss of donors and potential SP collection 8‐15 . This study ended as the pandemic began.…”

“…Importantly, there has not been any reported transmission of infectious blood borne diseases via plasma derivatives since 1994 6,7 . Several studies of blood donor deferrals have shown that donor deferral results in possibly losing a donor and that the longer a deferral, the higher the chances are of the donor not returning 8‐15 . We examined SP donor deferrals for the previous 3 years at 255 plasma donation centers in the United States.…”

“… 6 , 7 Several studies of blood donor deferrals have shown that donor deferral results in possibly losing a donor and that the longer a deferral, the higher the chances are of the donor not returning. 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 We examined SP donor deferrals for the previous 3 years at 255 plasma donation centers in the United States. While there have been numerous reports of deferral data in blood donors, this is the first comprehensive report of deferral patterns in SP donors.…”