{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,20]],"date-time":"2026-06-20T08:49:02Z","timestamp":1781945342167,"version":"3.54.5"},"reference-count":16,"publisher":"SAGE Publications","issue":"5","license":[{"start":{"date-parts":[[2024,1,19]],"date-time":"2024-01-19T00:00:00Z","timestamp":1705622400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Journal of Pharmacy Practice"],"published-print":{"date-parts":[[2024,10]]},"abstract":"<jats:p>Background: Four-factor prothrombin complex concentrate (4F-PCC) is indicated for vitamin K antagonist (VKA) reversal but is associated with thrombotic events (TE). In 2018, the institution revised 4F-PCC dosing for VKA reversal from INR and weight-based dosing to a fixed-dose of 1500 units. Objective: The purpose of this study was to compare hemostatic efficacy and TE rate of fixed-dose 4PCC to weight-based dosing. Methods: This was a retrospective, single-center, quasi-experimental study of adult patients who received 4F-PCC for VKA reversal from January 2014 through May 2016 (INR and weight-based dosing) or April through October 2018 (fixed-dosing). The primary endpoint was hemostatic efficacy, defined by achieving an INR of \u22641.4, or an INR of \u22641.7 with evidence of hemostasis. The key secondary endpoint was TE within 14 days of 4F-PCC administration. Data were analyzed using descriptive statistics, chi-squared for nominal data and Mann-Whitney U for ordinal and continuous data. Results: The study included 163 patients who received weight-based dosing and 45 who received fixed-dose 4F-PCC. Hemostatic efficacy was 76.9% of patients in the weight-based group and 77.4% of patients in the fixed-dose group ( P = .229). TE occurred in 13.5% of the weight-based vs 6.7% of the fixed-dose group ( P = .181). Conclusion: This study found no difference in hemostatic efficacy with fixed-dose 4F-PCC for VKA reversal compared to INR and weight-based dosing. The occurrence of TE was reduced by 50% with the 4F-PCC fixed-dose strategy; however, this difference was not statistically significant. Further randomized studies are needed to confirm these results.<\/jats:p>","DOI":"10.1177\/08971900241228779","type":"journal-article","created":{"date-parts":[[2024,1,19]],"date-time":"2024-01-19T12:54:22Z","timestamp":1705668862000},"page":"1099-1106","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":2,"title":["Hemostatic Efficacy and Safety of Weight-Based Versus Fixed-Dose 4F-PCC for Vitamin K Antagonist Reversal"],"prefix":"10.1177","volume":"37","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1188-8602","authenticated-orcid":false,"given":"Ashley E.","family":"Milkovits","sequence":"first","affiliation":[{"name":"Clinical Pharmacy Specialist, Department of Pharmacy, Carilion Roanoke Memorial Hospital, Roanoke, VA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-5857-8001","authenticated-orcid":false,"given":"David","family":"Sugrue","sequence":"additional","affiliation":[{"name":"Clinical Pharmacy Coordinator, Duke Raleigh Hospital, Raleigh, NC, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Janie","family":"Faris","sequence":"additional","affiliation":[{"name":"Clinical Pharmacy Specialist, Parkland Health, Dallas, TX, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jessica L.","family":"Schad","sequence":"additional","affiliation":[{"name":"Clinical Pharmacy Specialist, Department of Pharmacy, Carilion Roanoke Memorial Hospital, Roanoke, VA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kelly B.","family":"McAllister","sequence":"additional","affiliation":[{"name":"Clinical Pharmacy Manager, Carilion Roanoke Memorial Hospital, Roanoke, VA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2024,1,19]]},"reference":[{"key":"bibr1-08971900241228779","doi-asserted-by":"publisher","DOI":"10.1378\/chest.08-0674"},{"key":"bibr2-08971900241228779","volume-title":"Kcentra (Prothrombin Complex Concentrate [human]) [package Insert]","year":"2013"},{"key":"bibr3-08971900241228779","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2017.09.1085"},{"key":"bibr4-08971900241228779","unstructured":"Dietrich J, Faris J, Hoffman J, et al. Predictors of thromboembolic events after four-factor prothrombin complex concentrate. 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