{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,22]],"date-time":"2026-06-22T20:11:44Z","timestamp":1782159104228,"version":"3.54.5"},"reference-count":21,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2025,1,13]],"date-time":"2025-01-13T00:00:00Z","timestamp":1736726400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100012399","name":"Biomedical Advanced Research and Development Authority","doi-asserted-by":"publisher","award":["HHS010020160009c"],"award-info":[{"award-number":["HHS010020160009c"]}],"id":[{"id":"10.13039\/100012399","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100016318","name":"Cerus Corporation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100016318","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Transfusion"],"published-print":{"date-parts":[[2025,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Although alloimmunization risk of pathogen\u2010reduced (PR) platelets has been studied, the risk has not been reported with PR red blood cells (RBCs).<\/jats:p><\/jats:sec><jats:sec><jats:title>Study Design and Methods<\/jats:title><jats:p>In a Phase III, randomized, controlled trial (Red Cell Pathogen Inactivation), cardiac or thoracic\u2010aorta surgery patients were randomized to transfusion with amustaline\/glutathione PR versus conventional RBCs. Pre\u2010transfusion and Day 28 samples were evaluated for Human leukocyte antigen (HLA) Class I and Class II antibodies at low, medium, and high cutoff values.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The HLA alloimmunization analysis included 114 participants (53% female) in the PR and 113 (51% female) in the conventional RBC arms. In a modified intention\u2010to\u2010treat analysis, 13.7% (<jats:italic>N<\/jats:italic>\u2009=\u200929) and 7.2% (<jats:italic>N<\/jats:italic>\u2009=\u200915) developed new high\u2010level HLA Class I or Class II antibodies, respectively; however, there was no signal that PR\u2010RBCs affected the rate of HLA Class I (odds ratio (OR) 1.3 [95% confidence interval (CI) 0.62\u20132.9]) or Class II antibody formation (OR 0.99 [95% CI 0.35\u20132.8]). Female transfusion recipients had higher risk of developing new high\u2010level HLA Class I antibodies (OR 12.0 [95% CI 3.5\u201340.9]) and Class II antibodies (OR 5.0 [95% CI 1.4\u201317]). The mean number of RBC (5.5 vs. 3.6\u2009units, <jats:italic>p<\/jats:italic>\u2009=\u20090.018) and platelet (1.8 vs. 1.1\u2009units, <jats:italic>p<\/jats:italic>\u2009=\u20090.043) transfusions was higher in subjects with new high\u2010level HLA Class II antibodies.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>Receipt of amustaline\/glutathione PR\u2010RBC units did not affect HLA alloimmunization risk. Female sex and number of RBC and platelet transfusions were risk factors for the development of new high\u2010level HLA Class I and Class II antibodies.<\/jats:p><\/jats:sec>","DOI":"10.1111\/trf.18131","type":"journal-article","created":{"date-parts":[[2025,1,13]],"date-time":"2025-01-13T04:14:09Z","timestamp":1736741649000},"page":"459-465","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Human leukocyte antigen alloimmunization in a randomized trial of amustaline\/glutathione pathogen\u2010reduced red cells in complex cardiac surgery patients"],"prefix":"10.1111","volume":"65","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0526-2088","authenticated-orcid":false,"given":"Philip J.","family":"Norris","sequence":"first","affiliation":[{"name":"Vitalant Research Institute  San Francisco California USA"},{"name":"Department of Laboratory Medicine University of California, San Francisco  San Francisco California 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California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhanna","family":"Kaidarova","sequence":"additional","affiliation":[{"name":"Vitalant Research Institute  San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Henry","family":"Friend","sequence":"additional","affiliation":[{"name":"Cerus Corporation  Concord California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeanne","family":"Varrone","sequence":"additional","affiliation":[{"name":"Cerus Corporation  Concord California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8615-9869","authenticated-orcid":false,"given":"Laurence","family":"Corash","sequence":"additional","affiliation":[{"name":"Cerus Corporation  Concord California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nina","family":"Mufti","sequence":"additional","affiliation":[{"name":"Cerus Corporation  Concord California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6618-4744","authenticated-orcid":false,"given":"Richard J.","family":"Benjamin","sequence":"additional","affiliation":[{"name":"Cerus Corporation  Concord California 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