PMID- 33760230
OWN - NLM
STAT- MEDLINE
DCOM- 20210630
LR  - 20210703
IS  - 1537-2995 (Electronic)
IS  - 0041-1132 (Print)
IS  - 0041-1132 (Linking)
VI  - 61
IP  - 6
DP  - 2021 Jun
TI  - Personalized collection of plasma from healthy donors: A randomized controlled 
      trial of a novel technology-enabled nomogram.
PG  - 1789-1798
LID - 10.1111/trf.16389 [doi]
AB  - 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.
CI  - (c) 2021 The Authors. Transfusion published by Wiley Periodicals LLC. on behalf of 
      AABB.
FAU - Hartmann, Jan
AU  - Hartmann J
AUID- ORCID: 0000-0003-4978-8014
AD  - Haemonetics Corporation, Boston, Massachusetts, USA.
FAU - Ragusa, Michael J
AU  - Ragusa MJ
AD  - Haemonetics Corporation, Boston, Massachusetts, USA.
FAU - Burchardt, Elmar R
AU  - Burchardt ER
AD  - University of Witten/Herdecke, Witten, Germany.
FAU - Manukyan, Zorayr
AU  - Manukyan Z
AD  - ClinStatDevice, Lexington, Massachusetts, USA.
FAU - Popovsky, Mark A
AU  - Popovsky MA
AD  - Haemonetics Corporation, Boston, Massachusetts, USA.
FAU - Leitman, Susan F
AU  - Leitman SF
AD  - National Institutes of Health (NIH) Clinical Center, Bethesda, Maryland, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT04320823
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20210421
PL  - United States
TA  - Transfusion
JT  - Transfusion
JID - 0417360
SB  - IM
MH  - Adult
MH  - Blood Donors/classification
MH  - Blood Safety/*methods
MH  - Blood Specimen Collection/*methods
MH  - COVID-19/blood/epidemiology
MH  - Donor Selection/methods
MH  - Female
MH  - *Healthy Volunteers
MH  - Humans
MH  - Inventions
MH  - Male
MH  - Middle Aged
MH  - *Nomograms
MH  - Pandemics
MH  - Plasmapheresis
MH  - Precision Medicine/*methods
MH  - Transfusion Reaction/prevention & control
MH  - Young Adult
PMC - PMC8251497
OTO - NOTNLM
OT  - donor safety
OT  - nomogram
OT  - plasma
OT  - plasmapheresis
OT  - source plasma
COIS- Dr. Hartmann reports being employed by and holding equity interest in Haemonetics 
      Corp. Mr. Ragusa reports being employed by and holding equity interest in 
      Haemonetics Corp. and holding a related patent, assigned to Haemonetics Corp. (US 
      2018 / 0344910 A1). Dr. Burchardt, Dr. Manukyan, Dr. Popovsky, and Dr. Leitman 
      report consulting fees from Haemonetics Corp. Dr. Leitman's opinions do not 
      reflect the policy of the National Institutes of Health or the Department of 
      Health and Human Services.
EDAT- 2021/03/25 06:00
MHDA- 2021/07/01 06:00
PMCR- 2021/07/02
CRDT- 2021/03/24 13:01
PHST- 2021/03/09 00:00 [revised]
PHST- 2021/01/14 00:00 [received]
PHST- 2021/03/09 00:00 [accepted]
PHST- 2021/03/25 06:00 [pubmed]
PHST- 2021/07/01 06:00 [medline]
PHST- 2021/03/24 13:01 [entrez]
PHST- 2021/07/02 00:00 [pmc-release]
AID - TRF16389 [pii]
AID - 10.1111/trf.16389 [doi]
PST - ppublish
SO  - Transfusion. 2021 Jun;61(6):1789-1798. doi: 10.1111/trf.16389. Epub 2021 Apr 21.