{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,10]],"date-time":"2026-07-10T13:04:52Z","timestamp":1783688692387,"version":"3.55.0"},"reference-count":7,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2018,11,18]],"date-time":"2018-11-18T00:00:00Z","timestamp":1542499200000},"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","id":[{"id":"10.13039\/100012399","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100006438","name":"Office of the Assistant Secretary for Health","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006438","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100008360","name":"HHS","doi-asserted-by":"publisher","award":["HHSO100201300021C"],"award-info":[{"award-number":["HHSO100201300021C"]}],"id":[{"id":"10.13039\/100008360","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Transfusion"],"published-print":{"date-parts":[[2018,12]]},"abstract":"BACKGROUND<\/jats:title>Hemorrhage causes significant morbidity and mortality in people aged <65 years. A lyophilized platelet\u2010derived hemostatic agent (Thrombosomes) demonstrated hemostatic efficacy in animal models. We report the results of the first safety trial of autologous Thrombosomes given to normal subjects.<\/jats:p><\/jats:sec>STUDY DESIGN AND METHODS<\/jats:title>Ten subjects received autologous Thrombosomes prepared from their apheresis platelets, and five control subjects received a buffer solution. There were five cohorts, with three subjects per cohort (two in the Thrombosomes group and one in the control group). Doses escalated from 1\/1,000 to 1\/10 of a proposed efficacious dose. Cohorts 4 and 5 received the highest dose, but in Cohort 5, one\u2010half the dose was infused 2 hours apart. Cohorts 1 through 3 were monitored for 42 days, Cohorts 4 and 5 were monitored for 60 days using hematology, coagulation, and chemistry assays and antibody testing.<\/jats:p><\/jats:sec>RESULTS<\/jats:title>There were no serious adverse events (AEs) and no subject withdrawals. There were eight treatment\u2010related AEs (TRAEs) in 5 of 15 subjects (33%) (four in the Thrombosomes group and one in the control group). Of four subjects receiving the highest doses, three had TRAEs. One had elevated D\u2010dimer, prothrombin fragment 1 + 2, and white blood cell count (subject had concurrent upper respiratory tract infection); one had T\u2010wave inversions in precordial leads V2 and V3 without elevated troponin or symptoms; and one had a platelet autoantibody without change in platelet count. All subjects\u2019 TRAEs resolved by Day 21.<\/jats:p><\/jats:sec>CONCLUSION<\/jats:title>There were no serious AEs in this small study. Thrombosomes were considered safe at the doses assessed. Future, larger trials will be needed to further assess safety and efficacy.<\/jats:p><\/jats:sec>","DOI":"10.1111\/trf.14972","type":"journal-article","created":{"date-parts":[[2018,11,19]],"date-time":"2018-11-19T05:29:31Z","timestamp":1542605371000},"page":"2969-2977","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":44,"title":["Safety evaluation of a lyophilized platelet\u2010derived hemostatic product"],"prefix":"10.1111","volume":"58","author":[{"given":"Jeffrey","family":"Barroso","sequence":"first","affiliation":[{"name":"Research Institute, Bloodworks Northwest Seattle Washington"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barbara","family":"Osborne","sequence":"additional","affiliation":[{"name":"Research Institute, Bloodworks Northwest Seattle Washington"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gayle","family":"Teramura","sequence":"additional","affiliation":[{"name":"Research Institute, Bloodworks Northwest Seattle Washington"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Esther","family":"Pellham","sequence":"additional","affiliation":[{"name":"Research Institute, Bloodworks Northwest Seattle Washington"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Fitzpatrick","sequence":"additional","affiliation":[{"name":"Cellphire, Inc. Rockville Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ruth","family":"Biehl","sequence":"additional","affiliation":[{"name":"Cellphire, Inc. Rockville Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Yu","sequence":"additional","affiliation":[{"name":"Cellphire, Inc. Rockville Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joan","family":"Pehta","sequence":"additional","affiliation":[{"name":"Cellphire, Inc. Rockville Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sherrill J.","family":"Slichter","sequence":"additional","affiliation":[{"name":"Research Institute, Bloodworks Northwest Seattle Washington"},{"name":"University of Washington School of Medicine Seattle Washington"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,11,18]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.17226\/23511"},{"key":"e_1_2_8_3_1","volume-title":"The injury chart book: a graphical overview of the global overview of the global burden of injuries","author":"Peden M","year":"2002"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(96)07492-2"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1097\/TA.0b013e31819d86ad"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.12043"},{"key":"e_1_2_8_7_1","first-page":"261","article-title":"Trehalose stabilized freeze dried human platelets, Thrombosomes, reduce blood loss in thrombocytopenic rabbit ear bleed model by as much as 89.5%","volume":"99","author":"Fitzpatrick G","year":"2010","journal-title":"Vox Sang"},{"key":"e_1_2_8_8_1","first-page":"262","article-title":"Trehalose stabilized freeze dried human platelets, Thrombosomes, persist in ciruculation 24 hours after infusion and are non\u2010immunogenic in New Zealand white rabbits","volume":"99","author":"Fitzpatrick G","year":"2010","journal-title":"Vox Sang"}],"container-title":["Transfusion"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Ftrf.14972","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/trf.14972","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,11]],"date-time":"2023-09-11T10:09:39Z","timestamp":1694426979000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/trf.14972"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,11,18]]},"references-count":7,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2018,12]]}},"alternative-id":["10.1111\/trf.14972"],"URL":"https:\/\/doi.org\/10.1111\/trf.14972","archive":["Portico"],"relation":{},"ISSN":["0041-1132","1537-2995"],"issn-type":[{"value":"0041-1132","type":"print"},{"value":"1537-2995","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,11,18]]},"assertion":[{"value":"2018-04-17","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-08-16","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-11-18","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}