2021
DOI: 10.1111/trf.16389
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Abstract: Background Source plasma is essential to support the growing demand for plasma‐derived medicinal products. Supply is short, with donor availability further limited by the coronavirus disease 2019 (COVID‐19) pandemic. This study examined whether a novel, personalized, technology‐based nomogram was noninferior with regard to significant hypotensive adverse events (AEs) in healthy donors. Study Design and Methods IMPACT (IMproving PlasmA CollecTion) was a prospective, multicenter, double‐blinded, randomized, cont… Show more

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Cited by 12 publications
(25 citation statements)
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“…The study found that the new, personalized nomogram was noninferior as compared to the 1992 nomogram with regard to the primary safety endpoint of significant hypotensive donor adverse events 5 . Per one of the prespecified secondary endpoints, the study also found that donors in the experimental arm were, on average, able to donate significantly more plasma per donation 5 .…”
Section: Introductionmentioning
confidence: 94%
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“…The study found that the new, personalized nomogram was noninferior as compared to the 1992 nomogram with regard to the primary safety endpoint of significant hypotensive donor adverse events 5 . Per one of the prespecified secondary endpoints, the study also found that donors in the experimental arm were, on average, able to donate significantly more plasma per donation 5 .…”
Section: Introductionmentioning
confidence: 94%
“…The study found that the new, personalized nomogram was noninferior as compared to the 1992 nomogram with regard to the primary safety endpoint of significant hypotensive donor adverse events 5 . Per one of the prespecified secondary endpoints, the study also found that donors in the experimental arm were, on average, able to donate significantly more plasma per donation 5 . In addition, a comprehensive safety analysis did not show any statistically significant increase in the risk of significant hypotensive as well as nonhypotensive adverse events (such as citrate reactions or phlebotomy‐related issues) 5 …”
Section: Introductionmentioning
confidence: 98%
See 1 more Smart Citation
“…The IMproving PlasmA CollecTion (IMPACT) study was a multicenter double‐blinded randomized trial comparing a novel personalized nomogram (targeting 28.5% of calculated total plasma volume per donation) to the current nomogram for paid plasma donations (625, 750, or 800 ml based on donor weight) 29 . The personalized nomogram group saw collection of 8% more plasma per donation, without increasing adverse events.…”
Section: Donor Collections and Testingmentioning
confidence: 99%
“…However, because of its simplicity, the nomogram does not account for the donor's gender, height, BMI, or hematocrit. A personalized nomogram was explored by Hartmann et al through a multicenter double‐blinded, randomized, controlled trial comparing the current nomogram to an individualized approach 21 . The authors concluded that the tailored nomogram was non‐inferior to the current three‐tiered nomogram with regards to significant hypotensive AEs, though their approach was focused on increasing SP collection volumes rather than decreasing AEs for SP donors.…”
mentioning
confidence: 99%