{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,8]],"date-time":"2026-08-08T18:43:37Z","timestamp":1786214617468,"version":"build-2736575974"},"reference-count":34,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2026,5,21]],"date-time":"2026-05-21T00:00:00Z","timestamp":1779321600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,5,21]],"date-time":"2026-05-21T00:00:00Z","timestamp":1779321600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100012399","name":"Biomedical Advanced Research and Development Authority","doi-asserted-by":"publisher","award":["75A50121C000059"],"award-info":[{"award-number":["75A50121C000059"]}],"id":[{"id":"10.13039\/100012399","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Transfusion"],"published-print":{"date-parts":[[2026,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Prehospital plasma transfusion for patients at risk of hemorrhagic shock reduces mortality, but cold\u2010chain and logistical constraints limit product availability. This study reports the first\u2010in\u2010human clinical evaluation of a new spray\u2010dried plasma product, Frontline On\u2010Demand Plasma (ODP).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Twenty\u2010four healthy volunteers were sequentially enrolled into three dose\u2010escalation cohorts. Autologous apheresis plasma was processed into plasma frozen within 24\u2009h (PF24), with half of each collection manufactured into ODP. Cohort 1 (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20096) received 200\u2009mL ODP; Cohort 2 (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20096) received 400\u2009mL; and Cohort 3 (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200912) was a randomized, double\u2010blind crossover comparing 800\u2009mL ODP with 800\u2009mL PF24. Subjects were monitored for 28\u2009days after each infusion. The primary endpoint was treatment\u2010emergent adverse events (TEAEs).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>System verification data demonstrated preservation of protein content in spray\u2010dried plasma. All 24 participants completed the study and infusions were well tolerated. Thirty\u2010five TEAEs occurred in 18 subjects; 34 were unrelated or unlikely related to infusion. In Cohort 3, TEAEs occurred at similar frequencies after ODP and PF24. Headache was the most common TEAE. Minor coagulation parameter changes were observed but were not clinically significant. Out\u2010of\u2010range coagulation values were evenly distributed between treatment groups.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Spray\u2010dried plasma demonstrated a safety profile comparable to standard frozen plasma, with no thromboembolic events observed. Its durable plastic packaging and rapid reconstitution support its potential for widespread use in out\u2010of\u2010hospital care, including emergency and austere environments.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/trf.70262","type":"journal-article","created":{"date-parts":[[2026,5,22]],"date-time":"2026-05-22T06:09:46Z","timestamp":1779430186000},"page":"1495-1505","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Next generation spray\u2010dried on\u2010demand plasma: A multicenter, randomized, dose\u2010escalation, first\u2010in\u2010human safety study"],"prefix":"10.1111","volume":"66","author":[{"given":"Jose A.","family":"Cancelas","sequence":"first","affiliation":[{"name":"Connell and O'Reilly Families Cell Manipulation Core Facility Dana\u2010Farber Cancer Institute  Boston Massachusetts USA"},{"name":"Department of Medicine Harvard Medical School  Boston Massachusetts 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