{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,11]],"date-time":"2026-06-11T01:01:23Z","timestamp":1781139683061,"version":"3.54.1"},"reference-count":27,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2026,2,10]],"date-time":"2026-02-10T00:00:00Z","timestamp":1770681600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,2,10]],"date-time":"2026-02-10T00:00:00Z","timestamp":1770681600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100006432","name":"Terumo BCT","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006432","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vox Sanguinis"],"published-print":{"date-parts":[[2026,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background and Objectives<\/jats:title>\n                    <jats:p>\n                      Europe will ban di(2\u2010ethylhexyl) phthalate (DEHP), used in blood bags, after 1 July 2030. This two\u2010phase study assessed the in vitro quality and in vivo 24\u2010h post\u2010transfusion recovery (PTR) of whole blood\u2013derived leukoreduced red cell concentrates (RCCs) collected and processed in 1,2\u2010cyclohexane dicarboxylic acid diisononyl ester (DINCH)\u2010plasticized sets and stored for 42\u2009days in non\u2010DEHP Erythromate\u2010plasticized, a proprietary blend of DINCH and\n                      <jats:italic>N<\/jats:italic>\n                      \u2010butyryl\u2010tri\u2010\n                      <jats:italic>n<\/jats:italic>\n                      \u2010hexyl citrate (BTHC), disposable sets.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods<\/jats:title>\n                    <jats:p>\n                      In Phase 1, in vitro parameters of RCCs (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200932) stored in non\u2010DEHP sets containing phosphate\u2010adenine\u2010glucose\u2010guanosine\u2010saline\u2010mannitol (PAGGSM) were compared with those of RCCs stored in DEHP sets containing saline\u2010adenine\u2010glucose\u2010mannitol (SAGM) (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200924). These parameters were assessed against the European Directorate for the Quality of Medicines &amp; Health Care (EDQM) criteria. In Phase 2, PTR of 42\u2010day autologous non\u2010DEHP RCCs was evaluated using biotin\u2010labelled methods in 24 healthy participants and compared against the EDQM and the US Food and Drug Administration (FDA) criteria.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Phase 1 results showed that haemoglobin concentrations remained stable. Haemolysis in non\u2010DEHP\/PAGGSM disposable sets was below the EDQM limit (&lt;0.8%) with a 95% confidence limit (CL) of 0.25% on Day 42 and was significantly lower (0.22%\u2009\u00b1\u20090.11%) compared to DEHP\/SAGM (0.31%\u2009\u00b1\u20090.14%). In Phase 2, PTR exceeded the 75% threshold set by the EDQM and FDA in all infusions (lower CL: 88.3%), with a mean of 93.3%\u2009\u00b1\u20096.7%.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>RCCs stored in non\u2010DEHP\/PAGGSM disposable sets met the in vitro EDQM criteria for quality and in vivo EDQM and FDA criteria for transfusable RCCs, thereby providing a suitable alternative to current DEHP\u2010plasticized disposable sets.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial Registration<\/jats:title>\n                    <jats:p>\n                      The clinical trial was registered at the\n                      <jats:italic>World Health Organization\u2014International Clinical Trials Registry Platform<\/jats:italic>\n                      (ICTRP): NL\u2010OMON56734, registration date 30 April 2024.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/vox.70213","type":"journal-article","created":{"date-parts":[[2026,2,11]],"date-time":"2026-02-11T01:27:27Z","timestamp":1770773247000},"page":"789-800","source":"Crossref","is-referenced-by-count":0,"title":["In vitro and in vivo evaluation of leukoreduced red cell concentrates stored in non\u2010\n                    <scp>DEHP<\/scp>\n                    storage bags"],"prefix":"10.1111","volume":"121","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4923-2289","authenticated-orcid":false,"given":"Stefan F.","family":"van Wonderen","sequence":"first","affiliation":[{"name":"Department of Intensive Care Amsterdam UMC location University of Amsterdam  Amsterdam The Netherlands"},{"name":"Laboratory of Experimental Intensive Care and Anesthesiology Amsterdam UMC location University of Amsterdam  Amsterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4575-2874","authenticated-orcid":false,"given":"Christie","family":"Vermeulen","sequence":"additional","affiliation":[{"name":"Department of Product and Process Development Sanquin Blood Supply Foundation  Amsterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Johan","family":"Lagerberg","sequence":"additional","affiliation":[{"name":"Department of Product and Process Development Sanquin Blood Supply Foundation  Amsterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rombout B. E.","family":"van Amstel","sequence":"additional","affiliation":[{"name":"Department of Intensive Care Amsterdam UMC location University of Amsterdam  Amsterdam The Netherlands"},{"name":"Laboratory of Experimental Intensive Care and Anesthesiology Amsterdam UMC location University of Amsterdam  Amsterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leeann","family":"Ribble","sequence":"additional","affiliation":[{"name":"Clinical Affairs, Terumo BCT, Inc.  Lakewood Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rebecca L.","family":"Sedjo","sequence":"additional","affiliation":[{"name":"Clinical Affairs, Terumo BCT, Inc.  Lakewood Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jack","family":"Rhodes","sequence":"additional","affiliation":[{"name":"Clinical Affairs, Terumo BCT, Inc.  Lakewood Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E. Jane","family":"Clymer","sequence":"additional","affiliation":[{"name":"Scientific Affairs, Terumo BCT, Inc.  Lakewood Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander P. J.","family":"Vlaar","sequence":"additional","affiliation":[{"name":"Department of Intensive Care Amsterdam UMC location University of Amsterdam  Amsterdam The Netherlands"},{"name":"Laboratory of Experimental Intensive Care and Anesthesiology Amsterdam UMC location University of Amsterdam  Amsterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas R. L.","family":"Klei","sequence":"additional","affiliation":[{"name":"Department of Product and Process Development Sanquin Blood Supply Foundation  Amsterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,2,10]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1423-0410.1984.tb01603.x"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood.V64.6.1270.1270"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood.V71.2.448.448"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1423-0410.1985.tb00162.x"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.yrtph.2019.104546"},{"key":"e_1_2_9_7_1","unstructured":"Recommendation of the European Chemicals Agency of 10 July 2019 to amend the Annex XIV entries to REACH of DEHP BBP DBP and DIBP (list of substances subject to authorisation). Available from:https:\/\/echa.europa.eu\/documents\/10162\/13640\/axiv_amend_recommendation_phthalates_july2019_en.pdf\/1889866a\u2010bec3\u2010fe16\u20106322\u201067c16a13b09d. Last accessed 1 Oct 2025."},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.14583"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/vox.12982"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/vox.13177"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.12870"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/vox.13344"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.tmrv.2025.150904"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.yrtph.2016.01.013"},{"key":"e_1_2_9_15_1","unstructured":"European Directorate for the Quality of Medicines & Health Care (EDQM) Council of Europe Guide to the preparation use and quality assurance of blood components. Available from:https:\/\/www.edqm.eu\/en\/blood-guide. Last accessed 1 May 2025."},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1423-0410.1975.tb02756.x"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/cyto.10171"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.14435"},{"key":"e_1_2_9_19_1","volume-title":"BEST (Biomedical Excellence for Safer Transfusion) committee report on red blood cell recovery standards","author":"Blood Products Advisory Committee","year":"2008"},{"key":"e_1_2_9_20_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.14535"},{"key":"e_1_2_9_21_1","unstructured":"The R Project for Statistical Computing.The R project for statistical computing. Available from:http:\/\/www.r-project.org\/. Last accessed 3 Oct 2023."},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1537-2995.1999.39299154728.x"},{"key":"e_1_2_9_23_1","doi-asserted-by":"publisher","DOI":"10.1182\/bloodadvances.2022006987"},{"key":"e_1_2_9_24_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1423-0410.1991.tb00919.x"},{"key":"e_1_2_9_25_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1423-0410.1987.tb05066.x"},{"key":"e_1_2_9_26_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1537-2995.1991.31191096180.x"},{"key":"e_1_2_9_27_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.18286"},{"key":"e_1_2_9_28_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2011.03506.x"}],"container-title":["Vox Sanguinis"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/vox.70213","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/vox.70213","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/vox.70213","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,11]],"date-time":"2026-06-11T00:23:27Z","timestamp":1781137407000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/vox.70213"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,2,10]]},"references-count":27,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2026,6]]}},"alternative-id":["10.1111\/vox.70213"],"URL":"https:\/\/doi.org\/10.1111\/vox.70213","archive":["Portico"],"relation":{},"ISSN":["0042-9007","1423-0410"],"issn-type":[{"value":"0042-9007","type":"print"},{"value":"1423-0410","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,2,10]]}}}