{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,30]],"date-time":"2026-07-30T00:00:58Z","timestamp":1785369658474,"version":"3.55.0"},"reference-count":35,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2024,7,8]],"date-time":"2024-07-08T00:00:00Z","timestamp":1720396800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100016300","name":"Octapharma","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100016300","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100002918","name":"Gentofte Hospital","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100002918","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Transfusion"],"published-print":{"date-parts":[[2024,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Septic shock is associated with high morbidity and mortality, the endothelium plays an important role. Crystalloids is standard of care to maintain intravascular volume. Plasma is associated with improved endothelial integrity and restoration of the glycocalyx layer. We evaluated the efficacy and safety aspects of cell\u2010free and pathogen inactivated pooled plasma (OctaplasLG\u00ae) as resuscitation in septic shock patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Study Design and Methods<\/jats:title><jats:p>This randomized, investigator\u2010initiated phase IIa trial ran at a Danish single center intensive care unit, from 2017 to 2019. Patients were 18\u2009years of age or older with septic shock and randomized to fluid optimization with OctaplasLG\u00ae or Ringer\u2010acetate in the first 24\u2009h. The primary endpoints were changes in biomarkers indicative of endothelial activation, damage, and microvascular perfusion from baseline to 24\u2009h. Safety events and mortality were assessed during 90\u2009days.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Forty\u2010four patients were randomized, 20 to OctaplasLG versus 24 to Ringer\u2010acetate. The median age was 69, and 55% were men. Median Sequential Organ Failure Assessment score was 13. Baseline differences favoring the Ringer\u2010acetate group were observed. The OctaplasLG\u00ae group was resuscitated with 740\u2009mL plasma and the Ringer\u2010acetate group with 841\u2009mL crystalloids. There was no significant change in the microvascular perfusion or five biomarkers except VEGFR1 change, which was higher in patients receiving OctaplasLG\u00ae 0.12(SD 0.37) versus Ringer\u2010acetate \u22120.24 (SD 0.39), with mean difference 0.36 (95% CI, 0.13\u20130.59, <jats:italic>p<\/jats:italic>\u2009=\u2009.003) in favor of Ringer\u2010acetate.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>This study found that fluid resuscitation with OctaplasLG\u00ae in critically ill septic shock patients is feasible. Baseline confounding prevented assessment of the potential effect of OctaplasLG\u00ae.<\/jats:p><\/jats:sec>","DOI":"10.1111\/trf.17939","type":"journal-article","created":{"date-parts":[[2024,7,8]],"date-time":"2024-07-08T09:18:02Z","timestamp":1720430282000},"page":"1653-1661","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Plasma as endothelial rescue in septic shock: A randomized, phase 2a pilot trial"],"prefix":"10.1111","volume":"64","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4370-859X","authenticated-orcid":false,"given":"Niels E.","family":"Clausen","sequence":"first","affiliation":[{"name":"Department of Anesthesia and Intensive Care Copenhagen University Hospital \u2010Bispebjerg and Frederiksberg  Copenhagen Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian S.","family":"Meyhoff","sequence":"additional","affiliation":[{"name":"Department of Anesthesia and Intensive Care Copenhagen University Hospital \u2010Bispebjerg and Frederiksberg  Copenhagen Denmark"},{"name":"Department of Clinical Medicine University of Copenhagen  Copenhagen Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hanne H.","family":"Henriksen","sequence":"additional","affiliation":[{"name":"Department of Clinical Medicine University of Copenhagen  Copenhagen Denmark"},{"name":"Section for Transfusion Medicine, Capital Region Blood Bank, Rigshospitalet Copenhagen University Hospital  Copenhagen Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne","family":"Lindhardt","sequence":"additional","affiliation":[{"name":"Department of Anesthesia and Intensive Care Zealand University Hospital  K\u00f8ge Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frank C.","family":"Pott","sequence":"additional","affiliation":[{"name":"Department of Anesthesia and Intensive Care Copenhagen University Hospital \u2010Bispebjerg and Frederiksberg  Copenhagen Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas Bech","family":"Lunen","sequence":"additional","affiliation":[{"name":"Department of Anesthesia and Intensive Care Zealand University Hospital  K\u00f8ge Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5716-5899","authenticated-orcid":false,"given":"Mikkel","family":"Gybel\u2010Brask","sequence":"additional","affiliation":[{"name":"Section for Transfusion Medicine, Capital Region Blood Bank, Rigshospitalet Copenhagen University Hospital  Copenhagen Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Theis","family":"Lange","sequence":"additional","affiliation":[{"name":"Section of Biostatistics University of Copenhagen  Copenhagen Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P\u00e4r 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