{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,30]],"date-time":"2026-01-30T01:40:25Z","timestamp":1769737225395,"version":"3.49.0"},"reference-count":27,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2015,5,15]],"date-time":"2015-05-15T00:00:00Z","timestamp":1431648000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Cerus Corporation"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vox Sanguinis"],"published-print":{"date-parts":[[2015,11]]},"abstract":"<jats:sec><jats:title>Background and Objectives<\/jats:title><jats:p>A photochemical treatment process (<jats:styled-content style=\"fixed-case\">PCT<\/jats:styled-content>) utilizing amotosalen and <jats:styled-content style=\"fixed-case\">UVA<\/jats:styled-content> light (<jats:styled-content style=\"fixed-case\">INTERCEPT<\/jats:styled-content><jats:sup>\u2122<\/jats:sup> <jats:styled-content style=\"fixed-case\">B<\/jats:styled-content>lood <jats:styled-content style=\"fixed-case\">S<\/jats:styled-content>ystem) has been developed for inactivation of viruses, bacteria, parasites and leucocytes that can contaminate blood components intended for transfusion. The objective of this study was to further characterize the safety profile of <jats:styled-content style=\"fixed-case\">INTERCEPT<\/jats:styled-content>\u2010treated platelet components (<jats:styled-content style=\"fixed-case\">PCT<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">PLT<\/jats:styled-content>) administered across a broad patient population.<\/jats:p><\/jats:sec><jats:sec><jats:title>Materials and Methods<\/jats:title><jats:p>This open\u2010label, observational haemovigilance programme of <jats:styled-content style=\"fixed-case\">PCT<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">PLT<\/jats:styled-content> transfusions was conducted in 21 centres in 11 countries. All transfusions were monitored for adverse events within 24\u00a0h post\u2010transfusion and for serious adverse events (<jats:styled-content style=\"fixed-case\">SAE<\/jats:styled-content>s) up to 7\u00a0days post\u2010transfusion. All adverse events were assessed for severity (Grade 0\u20134), and causal relationship to <jats:styled-content style=\"fixed-case\">PCT<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">PLT<\/jats:styled-content> transfusion.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Over the course of 7\u00a0years in the study centres, 4067 patients received 19\u00a0175 <jats:styled-content style=\"fixed-case\">PCT<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">PLT<\/jats:styled-content> transfusions. Adverse events were infrequent, and most were of Grade 1 severity. On a per\u2010transfusion basis, 123 (0\u00b76%) were classified an acute transfusion reaction (<jats:styled-content style=\"fixed-case\">ATR<\/jats:styled-content>) defined as an adverse event related to the transfusion. Among these <jats:styled-content style=\"fixed-case\">ATR<\/jats:styled-content>s, the most common were chills (77, 0\u00b74%) and urticaria (41, 0\u00b72%). Fourteen <jats:styled-content style=\"fixed-case\">SAE<\/jats:styled-content>s were reported, of which 2 were attributed to platelet transfusion (&lt;0\u00b71%). No case of transfusion\u2010related acute lung injury, transfusion\u2010associated graft\u2010versus\u2010host disease, transfusion\u2010transmitted infection or death was attributed to the transfusion of <jats:styled-content style=\"fixed-case\">PCT<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">PLT<\/jats:styled-content>.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>This longitudinal haemovigilance safety programme to monitor <jats:styled-content style=\"fixed-case\">PCT<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">PLT<\/jats:styled-content> transfusions demonstrated a low rate of <jats:styled-content style=\"fixed-case\">ATR<\/jats:styled-content>s, and a safety profile consistent with that previously reported for conventional platelet components.<\/jats:p><\/jats:sec>","DOI":"10.1111\/vox.12287","type":"journal-article","created":{"date-parts":[[2015,5,15]],"date-time":"2015-05-15T17:51:15Z","timestamp":1431712275000},"page":"343-352","source":"Crossref","is-referenced-by-count":67,"title":["A prospective, active haemovigilance study with combined cohort analysis of 19\u00a0175 transfusions of platelet components prepared with amotosalen\u2013<scp>UVA<\/scp> photochemical treatment"],"prefix":"10.1111","volume":"109","author":[{"given":"F.","family":"Knutson","sequence":"first","affiliation":[{"name":"Department of Immunology, Genetics, and Pathology Uppsala University Uppsala Sweden"}]},{"given":"J.","family":"Osselaer","sequence":"additional","affiliation":[{"name":"Cliniques Universitaires de Mont Godinne Universite Catholique de Louvain Yvoir Belgium"}]},{"given":"L.","family":"Pierelli","sequence":"additional","affiliation":[{"name":"Department of Experimental Medicine Sapienza University of Roma Rome Italy"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2593-833X","authenticated-orcid":false,"given":"M.","family":"Lozano","sequence":"additional","affiliation":[{"name":"Department of Hemotherapy and Hemostasis CDB IDIBAPS Hospital Clinic Barcelona Spain"}]},{"given":"J.","family":"Cid","sequence":"additional","affiliation":[{"name":"Department of Hemotherapy and Hemostasis CDB IDIBAPS Hospital Clinic Barcelona Spain"}]},{"given":"R.","family":"Tardivel","sequence":"additional","affiliation":[{"name":"EFS Bretagne Rennes France"}]},{"given":"O.","family":"Garraud","sequence":"additional","affiliation":[{"name":"EFS Auvergne Loire St. Etienne France"}]},{"given":"T.","family":"Hervig","sequence":"additional","affiliation":[{"name":"Department of Immunology and Transfusion Medicine University of Bergen Bergen Norway"}]},{"given":"D.","family":"Domanovic","sequence":"additional","affiliation":[{"name":"Blood Transfusion Centre of Slovenia Ljubljana Slovenia"}]},{"given":"M.","family":"Cukjati","sequence":"additional","affiliation":[{"name":"Blood Transfusion Centre of Slovenia Ljubljana Slovenia"}]},{"given":"S.","family":"Gudmundson","sequence":"additional","affiliation":[{"name":"Blood Bank National University Hospital Reykjavik Iceland"}]},{"given":"I. 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