Evidence map›Paper›PMID 33760230›Full record

Trial reportTransfusion2021

Personalized collection of plasma from healthy donors: A randomized controlled trial of a novel technology-enabled nomogram.

Jan Hartmann, Michael J Ragusa, Elmar R Burchardt, Zorayr Manukyan, Mark A Popovsky, Susan F Leitman

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Transfusion, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Effect of Plasma Unit Weight and Donor Sex on Post-Donation Citrate Level: An Experimental Study on Plasmapheresis Donors.Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie · 2023
    Article
  7. Challenges for Plasma-Derived Medicinal Products.Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie · 2023
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Jan HartmannHaemonetics Corporation, Boston, Massachusetts, USA.ORCID 0000-0003-4978-8014
Michael J RagusaHaemonetics Corporation, Boston, Massachusetts, USA.
Elmar R BurchardtUniversity of Witten/Herdecke, Witten, Germany.
Zorayr ManukyanClinStatDevice, Lexington, Massachusetts, USA.
Mark A PopovskyHaemonetics Corporation, Boston, Massachusetts, USA.
Susan F LeitmanNational Institutes of Health (NIH) Clinical Center, Bethesda, Maryland, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSource 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

methodsIMPACT (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.

resultsA total of 3443 donors (mean [SD] BMI: 32 [7.74] kg/m

conclusionThis 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.

Indexed as

Healthy VolunteersNomogramsAdultBlood DonorsBlood SafetyBlood Specimen CollectionCOVID-19Donor SelectionFemaleHumansInventionsMaleMiddle AgedPandemicsPlasmapheresisPrecision Medicinedonor safetynomogramplasmaplasmapheresissource plasma

Identifiers

PMID33760230
PMCPMC8251497

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.