{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T19:55:27Z","timestamp":1791230127980,"version":"4.1.0"},"reference-count":29,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2019,7,25]],"date-time":"2019-07-25T00:00:00Z","timestamp":1564012800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Transfusion Medicine"],"published-print":{"date-parts":[[2019,8]]},"abstract":"<jats:title>Summary<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>To evaluate the effectiveness and safety of prothrombin complex concentrates (PCCs) in approved and off\u2010label indications.<\/jats:p><\/jats:sec><jats:sec><jats:title>Background<\/jats:title><jats:p>PCCs are approved for the urgent reversal of vitamin K antagonists (VKAs). Data concerning the efficacy, safety and dosing for off\u2010label indications are limited, but they are included in massive bleeding protocols.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This was a retrospective review of cases treated with four\u2010factor PCCs (4F\u2010PCCs) between January 2009 and 2016. Efficacy end\u2010points include: (i) VKA reversal efficacy assessed by international normalised ratio (INR) normalisation (&lt;1\u00b75) and (ii) clinical efficacy as bleeding cessation and\/or decreased number of transfused blood components and 24\u2010h mortality in bleeding coagulopathy. The safety end\u2010point is the incidence of thromboembolic events.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 328 patients were included (51\u00b78% male, median age 78\u2009years old). Indications were as follows: VKA reversal (66\u00b76%), bleeding coagulopathy (30\u00b75%) and direct anticoagulant (DOAC) reversal due to bleeding (2\u00b75%).<\/jats:p><jats:p>VKA reversal was effective in 97\u00b71% of patients, and 76\u00b75% demonstrated complete reversal (INR\u2009&lt;\u00a01\u00b75); only 34\u00b73% patients needed hemoderivatives. Prior to emergency procedures, PCCs achieved global responses in 83% of patients, with no bleeding complication during intervention. DOAC reversal was effective in 88\u00b79% of patients. Bleeding cessation was associated with the dose administered (<jats:italic>P<\/jats:italic>\u00a0=\u00a00\u00b7002). In coagulopathy bleeding, haemorrhage cessation, established by the International Society of Thrombosis and Haemostais (ISTH) definition, occurred in 56\u00b77% of massive bleeding events and in 42\u00b75% of other coagulopathies; 24\u2010h mortality was 30%, mainly related to active bleeding. Ten thrombotic episodes were observed (3\u00b71%).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>4F\u2010PCC was effective as adjuvant treatment with an acceptable safety profile, not only for the emergent reversal of VKAs but also for refractory coagulopathy associated with major bleeding.<\/jats:p><\/jats:sec>","DOI":"10.1111\/tme.12621","type":"journal-article","created":{"date-parts":[[2019,7,26]],"date-time":"2019-07-26T06:33:17Z","timestamp":1564122797000},"page":"268-274","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Safety and effectiveness of a prothrombin complex concentrate in approved and off\u2010label indications"],"prefix":"10.1111","volume":"29","author":[{"given":"M.","family":"Marcos\u2010Jubilar","sequence":"first","affiliation":[{"name":"Hematology Service Cl\u00ednica Universidad de Navarra  Pamplona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J. A.","family":"Garc\u00eda Erce","sequence":"additional","affiliation":[{"name":"Banco de Sangre y Tejidos de Navarra  Pamplona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"N.","family":"Mart\u00ednez\u2010Calle","sequence":"additional","affiliation":[{"name":"Department of Clinical Haematology Nottingham University Hospitals NHS Trust  Nottingham UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J. A.","family":"P\u00e1ramo","sequence":"additional","affiliation":[{"name":"Hematology Service Cl\u00ednica Universidad de Navarra  Pamplona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Mart\u00ednez Virto","sequence":"additional","affiliation":[{"name":"Emergency Department Hospital Universitario La Paz  Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Quintana\u2010D\u00edaz","sequence":"additional","affiliation":[{"name":"Intensive Medicine Hospital Universitario La Paz  Madrid 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