{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,10]],"date-time":"2026-07-10T13:05:47Z","timestamp":1783688747296,"version":"3.55.0"},"reference-count":27,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2021,12,20]],"date-time":"2021-12-20T00:00:00Z","timestamp":1639958400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100016300","name":"Octapharma","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100016300","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Transfusion"],"published-print":{"date-parts":[[2022,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>This study investigated the real\u2010world safety and tolerability of solvent\/detergent\u2010treated (S\/D) plasma for pediatric patients requiring therapeutic plasma exchange (TPE).<\/jats:p><\/jats:sec><jats:sec><jats:title>Study design and methods<\/jats:title><jats:p>LAS\u2010213 was a multicenter, open\u2010label, interventional, phase 4 study. Patients (\u22652 to \u226420\u2009years) receiving TPE therapy were eligible. A total plasma volume of 40\u201360\u2009ml\/kg was recommended, with an infusion rate not exceeding 0.020\u20130.025 citrate\/kg body weight\/min (&lt;1\u00a0ml\/kg body weight\/min). The primary endpoint was assessment of safety, monitoring the following: serious adverse events (SAEs), adverse drug reactions (ADRs), thrombotic events (TEs), thromboembolic events (TEEs), and specific laboratory tests.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In total, 41 children (2 to &lt;12\u2009years [<jats:italic>n<\/jats:italic>\u00a0=\u00a015]; 12 to &lt;17\u2009years [<jats:italic>n<\/jats:italic>\u00a0=\u00a013]; \u226517\u2009years [<jats:italic>n<\/jats:italic>\u00a0=\u00a013]) underwent 102 TPEs with a total of 135,137\u2009ml of S\/D plasma exchanged. Each patient group received between 1 and 6 TPEs (mean: 2.5 TPEs). Actual dose administered per TPE was 4\u201372\u2009ml\/kg (mean: 28.6\u00a0ml\/kg), with a mean total volume of 1324.9\u00a0ml (range: 113\u20134000\u2009ml). Overall safety was excellent for 96\/102 (94.0%) TPEs. Six TPEs had a \u201cmoderate\u201d safety profile for four patients experiencing eight ADRs. Of these, seven were mild in intensity and one (pyrexia) was moderate, all resolving by study end. Mild citrate toxicity (<jats:italic>n<\/jats:italic>\u00a0=\u00a02) was the most common ADR. One SAE was reported but was unrelated to the study drug. No TEs, TEEs, or changes in laboratory safety parameters were reported.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>S\/D plasma was well tolerated and demonstrated favorable safety, supporting the use of S\/D plasma for TPE in pediatrics.<\/jats:p><\/jats:sec>","DOI":"10.1111\/trf.16775","type":"journal-article","created":{"date-parts":[[2021,12,21]],"date-time":"2021-12-21T07:04:10Z","timestamp":1640070250000},"page":"396-405","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Safety and tolerability of solvent\/detergent\u2010treated plasma for pediatric patients requiring therapeutic plasma exchange: An open\u2010label, multicenter, postmarketing study"],"prefix":"10.1111","volume":"62","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2543-991X","authenticated-orcid":false,"given":"Cassandra D.","family":"Josephson","sequence":"first","affiliation":[{"name":"Departments of Pathology and Laboratory Medicine and Pediatrics Center for Transfusion and Cellular Therapies and Aflac Cancer and Blood Disorders Center, Emory University School of Medicine  Atlanta Georgia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stuart","family":"Goldstein","sequence":"additional","affiliation":[{"name":"Cincinnati Children's  Cincinnati Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Askenazi","sequence":"additional","affiliation":[{"name":"Children's of Alabama, University of Alabama at Birmingham  Birmingham Alabama USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9847-0470","authenticated-orcid":false,"given":"Claudia S.","family":"Cohn","sequence":"additional","affiliation":[{"name":"University of Minnesota  Minneapolis Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1721-0541","authenticated-orcid":false,"given":"Philip C.","family":"Spinella","sequence":"additional","affiliation":[{"name":"University of Pittsburg  Pittsburg Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ara","family":"Metjian","sequence":"additional","affiliation":[{"name":"University of Colorado, Anschutz Medical Campus  Aurora Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8692-4041","authenticated-orcid":false,"given":"Ross M.","family":"Fasano","sequence":"additional","affiliation":[{"name":"Departments of Pathology and Laboratory Medicine and Pediatrics Center for Transfusion and Cellular Therapies and Aflac Cancer and Blood Disorders Center, Emory University School of Medicine  Atlanta Georgia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lejla","family":"Music\u2010Aplenc","sequence":"additional","affiliation":[{"name":"University of Missouri\u2010Kansas City School of Medicine  Kansas City Missouri USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,12,20]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.transci.2019.04.007"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12882-017-0803-3"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.transci.2017.01.001"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/vox.12090"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00467-020-04744-8"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.transci.2006.05.014"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/jca.21705"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1423-0410.2007.00940.x"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1097\/TA.0000000000000629"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.transci.2006.08.008"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1093\/bja\/aer003"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood.V79.3.826.826"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.13964"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2008.01948.x"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/bjh.15082"},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.14245"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.3389\/fped.2020.00572"},{"key":"e_1_2_7_19_1","unstructured":"Octapharma.Octaplas prescribing information.https:\/\/www.octaplasus.com\/wp\u2010content\/uploads\/2021\/03\/20210202_pil_952_US_25.pdf(2021). 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