{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T15:40:12Z","timestamp":1791906012509,"version":"4.3.4"},"reference-count":22,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2015,7,1]],"date-time":"2015-07-01T00:00:00Z","timestamp":1435708800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100008322","name":"CSL Behring","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008322","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Transfusion"],"published-print":{"date-parts":[[2015,11]]},"abstract":"<jats:sec><jats:title>BACKGROUND<\/jats:title><jats:p>Plasma is commonly used for vitamin K antagonist (VKA) reversal, but observational studies suggest that it is associated with transfusion\u2010related adverse reactions (e.g., volume overload). However, this issue has not previously been addressed in a randomized controlled trial (RCT).<\/jats:p><\/jats:sec><jats:sec><jats:title>STUDY DESIGN AND METHODS<\/jats:title><jats:p>Factors associated with volume overload were examined using data from two Phase IIIb RCTs comparing plasma with four\u2010factor prothrombin complex concentrate (4F\u2010PCC, Beriplex\/Kcentra, CSL Behring) for urgent VKA reversal. VKA\u2010treated patients with major bleeding (NCT00708435) or requiring an urgent surgical or invasive procedure (NCT00803101) were randomly assigned (1:1) to receive either plasma or 4F\u2010PCC, concomitant with vitamin K. Adverse events (AEs) and serious AEs were prospectively captured up to Day 10 and 45, respectively. Volume overload predictors were evaluated on a univariate and multivariate basis.<\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p>A total of 388 patients (4F\u2010PCC, n\u2009=\u2009191; plasma, n\u2009=\u2009197) were enrolled. Volume overload occurred in 34 (9%) patients (4F\u2010PCC, n\u2009=\u20099; plasma, n\u2009=\u200925). In univariate analyses, use of plasma (vs. 4F\u2010PCC), use of nonstudy plasma and\/or platelets, race, history of congestive heart failure (CHF), and history of renal disease were associated with volume overload. In multivariate analyses, use of plasma (vs. 4F\u2010PCC), history of CHF, and history of renal disease were independent volume overload predictors. In an additional analysis restricted to volume overload events recorded up to Day 7, only use of plasma (vs. 4F\u2010PCC) was an independent volume overload predictor.<\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSIONS<\/jats:title><jats:p>After adjusting for other potential risk factors, plasma use was independently associated with a greater risk of volume overload than 4F\u2010PCC in patients requiring urgent VKA reversal.<\/jats:p><\/jats:sec>","DOI":"10.1111\/trf.13191","type":"journal-article","created":{"date-parts":[[2015,7,2]],"date-time":"2015-07-02T05:07:22Z","timestamp":1435813642000},"page":"2722-2729","source":"Crossref","is-referenced-by-count":63,"title":["Increased risk of volume overload with plasma compared with four\u2010factor prothrombin complex concentrate for urgent vitamin K antagonist reversal"],"prefix":"10.1111","volume":"55","author":[{"given":"Majed A.","family":"Refaai","sequence":"first","affiliation":[{"name":"University of Rochester Medicine Rochester New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joshua N.","family":"Goldstein","sequence":"additional","affiliation":[{"name":"Massachusetts General Hospital Boston Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin L.","family":"Lee","sequence":"additional","affiliation":[{"name":"UCLA School of Public Health Los Angeles California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Billie L.","family":"Durn","sequence":"additional","affiliation":[{"name":"CSL Behring King of Prussia Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"suffix":"Jr","given":"Truman J.","family":"Milling","sequence":"additional","affiliation":[{"name":"Seton\/UT Southwestern Clinical Research Institute of Austin, Dell Children's Medical Center University Medical Center at Brackenridge Austin Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ravi","family":"Sarode","sequence":"additional","affiliation":[{"name":"UT Southwestern Medical Center Dallas Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2015,7]]},"reference":[{"issue":"2","key":"e_1_2_8_2_1","doi-asserted-by":"crossref","first-page":"e44S\u201088S","DOI":"10.1378\/chest.11-2292","article-title":"Oral anticoagulant therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence\u2010Based Clinical Practice Guidelines","volume":"141","author":"Ageno W","year":"2012","journal-title":"Chest"},{"key":"e_1_2_8_3_1","unstructured":"US National Prescription Audit. 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