Personalized collection of plasma from healthy donors: A randomized controlled trial of a novel technology-enabled nomogram.
Transfusion
; 61(6): 1789-1798, 2021 06.
Article
in English
| MEDLINE | ID: covidwho-1148091
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 ANDMETHODS:
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/m2 ; 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.Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Blood Specimen Collection
/
Nomograms
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Precision Medicine
/
Blood Safety
/
Healthy Volunteers
Type of study:
Experimental Studies
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Observational study
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Prognostic study
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Randomized controlled trials
Limits:
Adult
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Female
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Humans
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Male
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Middle aged
/
Young adult
Language:
English
Journal:
Transfusion
Year:
2021
Document Type:
Article
Affiliation country:
Trf.16389
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