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10.1111/trf.16389

http://scihub22266oqcxt.onion/10.1111/trf.16389
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33760230!8251497!33760230
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suck abstract from ncbi


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pmid33760230      Transfusion 2021 ; 61 (6): 1789-1798
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  • Personalized collection of plasma from healthy donors: A randomized controlled trial of a novel technology-enabled nomogram #MMPMID33760230
  • Hartmann J; Ragusa MJ; Burchardt ER; Manukyan Z; Popovsky MA; Leitman SF
  • Transfusion 2021[Jun]; 61 (6): 1789-1798 PMID33760230show ga
  • 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, controlled trial carried out between January 6 and March 26, 2020, in three U.S plasma collection centers. Donors were randomly assigned to the current simplified 1992 nomogram (control) or a novel percent plasma nomogram (PPN) with personalized target volume calculation (experimental). Primary endpoint was the rate of significant hypotensive AEs. Noninferiority (NI) was tested with a margin of 0.15%. Collected plasma volume was a secondary endpoint. RESULTS: A total of 3443 donors (mean [SD] BMI: 32 [7.74] kg/m(2) ; 65% male) underwent 23,137 donations (median [range]: 6 [1-22] per subject). Ten significant hypotensive AEs were observed (six control; four experimental), with model-based AE incidence rate estimates (95% CI) of 0.051% (0.020%-0.114%) and 0.035% (0.010%-0.094%), respectively (p = .58). NI was met at an upper limit of 0.043% versus the predefined margin of 0.15%. There was no statistical difference between total AEs (all AE types: p = .32). Mean plasma volume collected was 777.8 ml (control) versus 841.7 ml (experimental); an increase of 63.9 ml per donation (8.2%; p < .0001). CONCLUSION: This trial showed that a novel personalized nomogram approach in healthy donors allowed approximately 8% more plasma per donation to be collected without impairing donor safety.
  • |*Healthy Volunteers[MESH]
  • |*Nomograms[MESH]
  • |Adult[MESH]
  • |Blood Donors/classification[MESH]
  • |Blood Safety/*methods[MESH]
  • |Blood Specimen Collection/*methods[MESH]
  • |COVID-19/blood/epidemiology[MESH]
  • |Donor Selection/methods[MESH]
  • |Female[MESH]
  • |Humans[MESH]
  • |Inventions[MESH]
  • |Male[MESH]
  • |Middle Aged[MESH]
  • |Pandemics[MESH]
  • |Plasmapheresis[MESH]
  • |Precision Medicine/*methods[MESH]
  • |Transfusion Reaction/prevention & control[MESH]


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