{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,14]],"date-time":"2025-11-14T21:02:42Z","timestamp":1763154162868,"version":"3.40.5"},"reference-count":21,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2021,4,21]],"date-time":"2021-04-21T00:00:00Z","timestamp":1618963200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Transfusion"],"published-print":{"date-parts":[[2021,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Source plasma is essential to support the growing demand for plasma\u2010derived medicinal products. Supply is short, with donor availability further limited by the coronavirus disease 2019 (COVID\u201019) pandemic. This study examined whether a novel, personalized, technology\u2010based nomogram was noninferior with regard to significant hypotensive adverse events (AEs) in healthy donors.<\/jats:p><\/jats:sec><jats:sec><jats:title>Study Design and Methods<\/jats:title><jats:p>IMPACT (IMproving PlasmA CollecTion) was a prospective, multicenter, double\u2010blinded, 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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 3443 donors (mean [SD] BMI: 32 [7.74] kg\/m<jats:sup>2<\/jats:sup>; 65% male) underwent 23,137 donations (median [range]: 6 [1\u201322] per subject). Ten significant hypotensive AEs were observed (six control; four experimental), with model\u2010based AE incidence rate estimates (95% CI) of 0.051% (0.020%\u20130.114%) and 0.035% (0.010%\u20130.094%), respectively (<jats:italic>p<\/jats:italic>\u00a0=\u00a0.58). 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:<jats:italic>p<\/jats:italic>\u00a0=\u00a0.32). Mean plasma volume collected was 777.8\u00a0ml (control) versus 841.7\u00a0ml (experimental); an increase of 63.9\u00a0ml per donation (8.2%;<jats:italic>p<\/jats:italic>\u2009&lt;\u2009.0001).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec>","DOI":"10.1111\/trf.16389","type":"journal-article","created":{"date-parts":[[2021,3,24]],"date-time":"2021-03-24T12:11:53Z","timestamp":1616587913000},"page":"1789-1798","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["Personalized collection of plasma from healthy donors: A randomized controlled trial of a novel technology\u2010enabled nomogram"],"prefix":"10.1111","volume":"61","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4978-8014","authenticated-orcid":false,"given":"Jan","family":"Hartmann","sequence":"first","affiliation":[{"name":"Haemonetics Corporation Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael J.","family":"Ragusa","sequence":"additional","affiliation":[{"name":"Haemonetics Corporation Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elmar R.","family":"Burchardt","sequence":"additional","affiliation":[{"name":"University of Witten\/Herdecke Witten Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zorayr","family":"Manukyan","sequence":"additional","affiliation":[{"name":"ClinStatDevice Lexington Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mark A.","family":"Popovsky","sequence":"additional","affiliation":[{"name":"Haemonetics Corporation Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Susan F.","family":"Leitman","sequence":"additional","affiliation":[{"name":"National Institutes of Health (NIH) Clinical Center Bethesda Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2021,4,21]]},"reference":[{"key":"e_1_2_9_2_1","unstructured":"Bult J.The World Needs Plasma: From the USA and Other Countries. Plasma Protein Therapeutics Association. Presented at: Plasma Product Biotechnology Meeting;2017. Available from:https:\/\/www.pptaglobal.org\/images\/presentations\/2017\/2017-_The_World_Needs_Plasma.pdf. Accessed August 16 2020."},{"key":"e_1_2_9_3_1","unstructured":"FDA: Information About Immune Globulin (Human) Product Shortage.U.S. Food & Drug Administration; published August 16 2019. Available from:https:\/\/www.fda.gov\/vaccines-blood-biologics\/safety-availability-biologics\/information-about-immune-globulin-human-product-shortage. Accessed July 27 2020."},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.15835"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.16078"},{"key":"e_1_2_9_6_1","doi-asserted-by":"crossref","unstructured":"FDA Issues Emergency Use Authorization for Convalescent Plasma as Potential Promising COVID\u201319 Treatment Another Achievement in Administration's Fight Against Pandemic. U.S. Food and Drug Administration; published August2020. Available from:https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-issues-emergency-use-authorization-convalescent-plasma-potential-promising-covid-19-treatment. Accessed September 11 2020.","DOI":"10.1021\/cen-09833-buscon4"},{"key":"e_1_2_9_7_1","unstructured":"FDA In Brief: FDA Updates Emergency Use Authorization for COVID\u201019 Convalescent Plasma to Reflect New Data. U.S. Food and Drug Administration.2021.https:\/\/www.fda.gov\/news-events\/fda-brief\/fda-brief-fda-updates-emergency-use-authorization-covid-19-convalescent-plasma-reflect-new-data. Accessed March 05 2021."},{"key":"e_1_2_9_8_1","unstructured":"Volume Limits \u2010 Automated Collection of Source Plasma. Received by All Registered Blood Establishments. U.S. Food & Drug Administration.www.fda.gov\/media\/70951\/download. 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