The American journal of emergency medicine · 2025
Evaluating the use of fixed versus variable dosing of 4-factor prothrombin complex concentrate in anticoagulant-related major bleeding.
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Schrader Elizabeth, Zinser Brianna, Kulhari Ashish, Craven Cody
Аннотация
BACKGROUND/OBJECTIVE: 4-factor prothrombin complex concentrate (4F-PCC) is used for reversal of vitamin K antagonists (VKA) and oral factor Xa (FXa) inhibitors in patients with major bleeding, including gastrointestinal bleeding and intracranial hemorrhage (ICH), and in those requiring emergent surgical intervention. Fixed dose 4F-PCC may offer the advantage of decreased cost and simplified administration. The objective of this study was to evaluate the effectiveness of fixed dose versus variable dose 4F-PCC in the achievement of hemostasis in VKA and FXa-associated major bleeding.
METHODS: Single-center, retrospective cohort study of patients who received 4F-PCC from January 1, 2018 through August 31, 2023. The primary outcome of effective hemostasis was based on the International Society on Thrombosis and Hemostasis definition.
RESULTS: Overall, baseline characteristics were similar between groups. The primary endpoint of effective hemostasis was achieved by 57 % of patients in the fixed dose group and 53 % of patients in the variable dose group (Risk difference [RD] 3.7 %, 95 % CI -14.5 to 22.0). The incidence of thromboembolic events within 7 days of 4F-PCC was lower in the fixed dose group compared with the variable dose group, at 4.2 % and 10.6 %, respectively (RD 6.4 %, 95 % CI -16.4 to 3.5). The average cost of 4F-PCC was $7023 in the fixed dose group versus $11,311 in the variable dose group with a between-group difference of $4288 (95 % CI 3150 to 5425). These results were consistent across all types and severities of anticoagulant-associated major bleeding.
CONCLUSIONS: In this study, fixed dose 4F-PCC was as effective as variable dose 4F-PCC in the achievement of hemostatic efficacy for VKA and FXa-associated major bleeding with a significantly lower overall cost.
METHODS: Single-center, retrospective cohort study of patients who received 4F-PCC from January 1, 2018 through August 31, 2023. The primary outcome of effective hemostasis was based on the International Society on Thrombosis and Hemostasis definition.
RESULTS: Overall, baseline characteristics were similar between groups. The primary endpoint of effective hemostasis was achieved by 57 % of patients in the fixed dose group and 53 % of patients in the variable dose group (Risk difference [RD] 3.7 %, 95 % CI -14.5 to 22.0). The incidence of thromboembolic events within 7 days of 4F-PCC was lower in the fixed dose group compared with the variable dose group, at 4.2 % and 10.6 %, respectively (RD 6.4 %, 95 % CI -16.4 to 3.5). The average cost of 4F-PCC was $7023 in the fixed dose group versus $11,311 in the variable dose group with a between-group difference of $4288 (95 % CI 3150 to 5425). These results were consistent across all types and severities of anticoagulant-associated major bleeding.
CONCLUSIONS: In this study, fixed dose 4F-PCC was as effective as variable dose 4F-PCC in the achievement of hemostatic efficacy for VKA and FXa-associated major bleeding with a significantly lower overall cost.