{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,5,14]],"date-time":"2025-05-14T02:06:21Z","timestamp":1747188381784,"version":"3.40.5"},"reference-count":10,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2023,10,15]],"date-time":"2023-10-15T00:00:00Z","timestamp":1697328000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100015135","name":"Haemonetics Corporation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100015135","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Transfusion"],"published-print":{"date-parts":[[2023,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Source plasma collections are needed to satisfy the growing demand for plasma\u2010derived medicinal products. The US plasma collection target volume has been guided by a standard weight\u2010based FDA\u2010issued nomogram (STAN) since 1992. In this research, large\u2010scale US\u2010based real\u2010world data (RWD) were analyzed to confirm the safety and volume gains of a newly introduced personalized nomogram (PERS) that was previously studied in a premarket randomized controlled environment.<\/jats:p><\/jats:sec><jats:sec><jats:title>Study Design and Methods<\/jats:title><jats:p>A non\u2010inferiority (NI) analysis was conducted to compare the novel nomogram's significant hypotensive adverse event (AE) incidence rate with large historical standard nomogram AE datasets. Additionally, the average target volumes and donor return rates were compared for collections following PERS and STAN.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 4,816,784 donations (PERS) by 414,957 donors resulted in a rate of 0.0998% (95% CI [0.0970, 0.1027]) significant hypotensive AEs. NI analysis suggested strong non\u2010inferiority of the new technology (\u0394\u2009=\u2009\u22120.0082%, 95% CI [\u22120.0113, \u22120.0050], prespecified NI margin\u2009=\u20090.1080). Average plasma collection target volumes increased by 66.39\u2009mL (8.49%; <jats:italic>p<\/jats:italic>\u2009&lt;\u2009.0001). Consecutive weekly donor return rates were consistent between the two nomograms (PERS: 73.6%, 95% CI [69.6%\u201376.7%]; STAN: 74.1%, 95% CI [66.1%\u201377.2%]).<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>This analysis confirms in a large\u2010scale real\u2010world dataset the key safety parameter and collection benefit of a novel, technology\u2010enabled nomogram. The nomogram may help meet the growing demand for plasma\u2010derived therapies by providing approximately 8.5% more plasma per donation on average while maintaining donor safety and return rates.<\/jats:p><\/jats:sec>","DOI":"10.1111\/trf.17579","type":"journal-article","created":{"date-parts":[[2023,10,15]],"date-time":"2023-10-15T21:00:27Z","timestamp":1697403627000},"page":"2256-2264","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Large\u2010scale real\u2010world data analysis of source plasma collections using a novel technology\u2010enabled nomogram"],"prefix":"10.1111","volume":"63","author":[{"ORCID":"https:\/\/orcid.org\/0009-0007-1858-0807","authenticated-orcid":false,"given":"Eva","family":"Hellman","sequence":"first","affiliation":[{"name":"Global Medical Office Haemonetics Corporation  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zorayr","family":"Manukyan","sequence":"additional","affiliation":[{"name":"ClinStatDevice  Lexington Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Karen","family":"Mkhitaryan","sequence":"additional","affiliation":[{"name":"ClinStatDevice  Lexington Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Karen","family":"Heidarsdottir","sequence":"additional","affiliation":[{"name":"Quality and Postmarket Surveillance Haemonetics Corporation  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael J.","family":"Ragusa","sequence":"additional","affiliation":[{"name":"Research and Development Haemonetics Corporation  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4978-8014","authenticated-orcid":false,"given":"Jan","family":"Hartmann","sequence":"additional","affiliation":[{"name":"Global Medical Office Haemonetics Corporation  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2023,10,15]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/ajh.25817"},{"key":"e_1_2_9_3_1","unstructured":"Volume Limits \u2013 Automated Collection of Source Plasma.U.S. food & drug administration.1992. Available from:https:\/\/www.fda.gov\/media\/70951\/downloadAccessed May 15 2023."},{"key":"e_1_2_9_4_1","unstructured":"BK200498 \u2013 NexSys PCS Plasma Collection System with Persona Technology.U.S. food & drug administration.2020. Available from:https:\/\/www.fda.gov\/vaccines-blood-biologics\/substantially-equivalent-510k-device-information\/bk200498-nexsys-pcs-plasma-collection-system-persona-technologyAccessed May 15 2023."},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.16389"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.16610"},{"volume-title":"Standard for Recording Donor Adverse Events, Version 2.0","year":"2018","author":"IQPP","key":"e_1_2_9_7_1"},{"key":"e_1_2_9_8_1","unstructured":"GustafsonM.Source plasma donor hemovigilance activities and results. Oral presentation at: AABB annual meeting October 8 2017. San Diego CA."},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.16612"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.16078"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood.2021015370"}],"container-title":["Transfusion"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/trf.17579","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,2,8]],"date-time":"2024-02-08T07:06:53Z","timestamp":1707376013000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/trf.17579"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,10,15]]},"references-count":10,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2023,12]]}},"alternative-id":["10.1111\/trf.17579"],"URL":"https:\/\/doi.org\/10.1111\/trf.17579","archive":["Portico"],"relation":{},"ISSN":["0041-1132","1537-2995"],"issn-type":[{"type":"print","value":"0041-1132"},{"type":"electronic","value":"1537-2995"}],"subject":[],"published":{"date-parts":[[2023,10,15]]},"assertion":[{"value":"2023-08-11","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-10-03","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-10-15","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}