• Michael T Bitonti, Rachel L Rumbarger, Randall K Absher, and Lisa M Curran.
• Department of Pharmacy, Moses H. Cone Memorial Hospital, Greensboro, North Carolina.
• J Emerg Med. 2020 Feb 1; 58 (2): 324-329.

BackgroundFour-factor prothrombin complex concentrate (4F-PCC) is the standard of care for reversal of vitamin K antagonists (VKAs). Research has demonstrated noninferior efficacy with the use of lower, fixed-dose strategies for 4F-PCC dosing.ObjectivesWe compared a fixed-dose 4F-PCC protocol to weight-based dosing at our institution.MethodsThis was a multicenter, noninferiority, interventional, quasiexperimental cohort study including subjects who were administered 4F-PCC for VKA reversal. The retrospective cohort consisted of subjects given a weight-based dose of 4F-PCC dependent on international normalized ratio (INR). The prospective cohort was managed with a fixed-dose protocol. The fixed dose was 1500 units of factor IX unless subjects weighed >100 kg or had a baseline INR >7.5, in which case the dose was 2000 units of factor IX. The primary endpoint was achievement of a postinfusion INR of <2. Secondary endpoints included achievement postinfusion INR <1.5, mean 24-h INR, 7-day mortality, and 7-day venous thromboembolic events.ResultsTwenty-four subjects were enrolled in the prospective cohort and 30 in the retrospective cohort. A postinfusion INR <2 was achieved in 96% of subjects in the retrospective cohort and 95% in the prospective cohort (p = 0.0035 for noninferiority). A postinfusion INR <1.5 occurred in 90% of subjects in the retrospective cohort and 75% in the prospective cohort (p > 0.4 for noninferiority). There were no significant differences in 24-h postinfusion INRs, mortality, or venous thromboembolic events.ConclusionThe use of a fixed-dose 4F-PCC protocol is safe and effective for the rapid reversal of VKA-associated anticoagulation.Copyright © 2019 Elsevier Inc. All rights reserved.

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