{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T00:18:39Z","timestamp":1793146719381,"version":"4.5.0"},"reference-count":32,"publisher":"American Medical Association (AMA)","issue":"20","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA"],"published-print":{"date-parts":[[2025,5,27]]},"abstract":"\n Importance<\/jats:title>\n Excessive bleeding is a common and prognostically important complication of cardiac surgery. For bleeding related to coagulation factor deficiency, frozen plasma is the most used therapy. Preliminary trials indicate that 4-factor prothrombin complex concentrate (PCC) may be a suitable alternative.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To compare the efficacy and safety of PCC with frozen plasma in patients undergoing cardiac surgery with coagulopathic bleeding.<\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n Unblinded randomized noninferiority controlled clinical trial at 12 hospitals in Canada and the US involving adults (\u226518 years) who had developed bleeding related to coagulation factor deficiency after termination of cardiopulmonary bypass during surgery (November 30, 2022, to May 28, 2024). Final 30-day follow-up visit was completed on June 28, 2024.<\/jats:p>\n <\/jats:sec>\n \n Intervention<\/jats:title>\n A total of 265 patients were randomized to receive PCC (1500 IU \u226460 kg; 2000 IU &amp;gt;60 kg) and 263, frozen plasma (3 U \u226460 kg; 4 U &amp;gt;60 kg) in the operating room. A second dose was allowed over the next 24 hours if indicated; thereafter, only frozen plasma could be used.<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n The primary outcome was hemostatic response (effective if no hemostatic interventions occurred from 60 minutes to 24 hours after treatment initiation). The noninferiority of PCC vs frozen plasma was assessed using a 10% margin and a 1-sided \u03b1 of .025, with subsequent testing for superiority if noninferiority was demonstrated. Secondary outcomes included allogeneic blood transfusions and adverse events. Patients were followed up until postoperative day 30.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Of 538 enrolled patients, 420 patients (median age, 66 years [IQR, 57-73 years]; 74%, male; 10%, Asian; 1%, Black; and 65%, White) were included in the primary analysis; of those, 296 (70%) underwent complex surgeries. Compared with the 207 patients in the frozen plasma group, the 213 patients in the PCC group had higher hemostatic effectiveness (166 [77.9%] vs 125 [60.4%]; difference, 17.6%; 95% CI, 8.7%-26.4%;\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001 for noninferiority and superiority) and had received fewer transfusions including red blood cells, platelets, and noninvestigational frozen plasma units (mean, 6.6 units; 95% CI, 5.7-7.7 vs 9.3 units; 95% CI, 8.0-10.8; difference, 2.7; 95% CI, 1.0-4.4;\n P<\/jats:italic>\n \u2009=\u2009.002). Seventy-seven patients (36.2%) in the PCC group vs 98 (47.3%) in the frozen plasma group experienced serious adverse events (relative risk [RR], 0.76; 95% CI, 0.61-0.96;\n P<\/jats:italic>\n \u2009=\u2009.02). Twenty-two patients (10.3%) in the PCC group and 39 (18.8%) in the frozen plasma group had acute kidney injury (RR, 0.55; 95% CI, 0.34-0.89;\n P<\/jats:italic>\n \u2009=\u2009.02).\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n In this unblinded randomized clinical trial, PCC had superior hemostatic efficacy and safety advantages to frozen plasma among patients requiring coagulation factor replacement for bleeding during cardiac surgery.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n ClinicalTrials.gov Identifier:\n NCT05523297<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jama.2025.3501","type":"journal-article","created":{"date-parts":[[2025,3,29]],"date-time":"2025-03-29T13:30:24Z","timestamp":1743255024000},"page":"1781","source":"Crossref","is-referenced-by-count":69,"title":["Prothrombin Complex Concentrate vs Frozen Plasma for Coagulopathic Bleeding in Cardiac Surgery"],"prefix":"10.1001","volume":"333","author":[{"given":"Keyvan","family":"Karkouti","sequence":"first","affiliation":[{"name":"Department of Anesthesia and Pain Management, University Health Network, Sinai Health, Women\u2019s College Hospital, University of Toronto, Toronto, Ontario, Canada"},{"name":"Peter Munk Cardiac Centre and Toronto General Hospital Research Institute, University Health Network, Toronto, Ontario, Canada"},{"name":"Department of Anesthesiology and Pain Medicine, University of Toronto, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeannie L.","family":"Callum","sequence":"additional","affiliation":[{"name":"Department of Pathology and Molecular Medicine, Kingston Health Sciences Centre and Queen\u2019s University, Kingston, Ontario, Canada"},{"name":"Sunnybrook Research Institute, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Justyna","family":"Bartoszko","sequence":"additional","affiliation":[{"name":"Department of Anesthesia and Pain Management, University Health Network, Sinai Health, Women\u2019s College Hospital, University of Toronto, Toronto, Ontario, Canada"},{"name":"Peter Munk Cardiac Centre and Toronto General Hospital Research Institute, University Health Network, Toronto, Ontario, Canada"},{"name":"Department of Anesthesiology and Pain Medicine, University of Toronto, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenichi A.","family":"Tanaka","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology, University of Oklahoma Health Sciences Center, Oklahoma City"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sigurd","family":"Knaub","sequence":"additional","affiliation":[{"name":"Octapharma AG, Lachen, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sukhpal","family":"Brar","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology and Perioperative Medicine, Royal Columbian Hospital, Vancouver, British Columbia, Canada"},{"name":"University of British Columbia, Vancouver, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kamrouz","family":"Ghadimi","sequence":"additional","affiliation":[{"name":"Clinical Research Unit, Department of Anesthesiology & Critical Care, Duke University Health System, Durham, North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antoine","family":"Rochon","sequence":"additional","affiliation":[{"name":"Department of Anesthesia, University of Montreal, Montreal Heart Institute, Montreal, Quebec, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Darren","family":"Mullane","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology, Pharmacology & Therapeutics, University of British Columbia, Canada"},{"name":"Vancouver General Hospital, Vancouver, British Columbia, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Etienne J.","family":"Couture","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology, Quebec Heart and Lung Institute, Laval University, Quebec, Quebec, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yulia","family":"Lin","sequence":"additional","affiliation":[{"name":"Precision Diagnostics and Therapeutics Program, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada"},{"name":"Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher","family":"Harle","sequence":"additional","affiliation":[{"name":"London Health Sciences Centre, London, Ontario, Canada"},{"name":"Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michelle","family":"Zeller","sequence":"additional","affiliation":[{"name":"Micheal G. 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