Trial reportAdvances in therapy2026
Effectiveness of Four-Factor Prothrombin Complex Concentrate Versus Plasma in Patients on Vitamin K Antagonists Undergoing Urgent Orthopedic Surgery: A Post Hoc Analysis.
Trial report in Advances in therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00803101 (An Open-label, Randomized, Multicenter Phase IIIb Study to Assess the Efficacy, Safety and Tolerance of BERIPLEX® P/N Compared With Plasma for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Subjects Requiring an Urgent Surgical Procedure), which is not on this map. Not yet cited in PubMed.
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An Open-label, Randomized, Multicenter Phase IIIb Study to Assess the Efficacy, Safety and Tolerance of BERIPLEX® P/N Compared With Plasma for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Subjects Requiring an Urgent Surgical Procedure
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4 authors.
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Abstract
introductionVitamin K antagonist (VKA) reversal is often required to prevent bleeding during urgent surgeries. This post hoc analysis evaluated the efficacy of four-factor prothrombin complex concentrate (4F-PCC) versus plasma for VKA reversal in a subgroup of patients requiring urgent orthopedic surgery.
methodsA phase 3b randomized controlled trial compared 4F-PCC with plasma for VKA reversal in patients aged ≥ 18 years on VKA therapy with an international normalized ratio (INR) ≥ 2 needing urgent surgical or invasive interventions. This post hoc analysis evaluated the subgroup of patients undergoing urgent orthopedic surgery. The primary endpoints were hemostatic efficacy and rapid INR reduction. Secondary endpoints included time to INR correction (INR ≤ 1.3) and levels of vitamin K-dependent factors post infusion.
resultsOverall, 51 patients were included in the analysis. Excellent/good hemostatic efficacy was reported in 83.3% and 71.4% of patients receiving 4F-PCC and plasma, respectively (p = 0.39). Rapid INR reduction was achieved by 43.3% in the 4F-PCC group and 0.0% in the plasma group (p < 0.001), with all vitamin K-dependent factors median activity levels being significantly higher in the 4F-PCC group up to 3 h after the start of infusion. The median time to surgery was 5.8 h and 19.2 h for the 4F-PCC and plasma groups, respectively (p < 0.001). There was no significant difference in the safety outcomes or mortality between the groups.
conclusionThe use of 4F-PCC for urgent reversal of VKA therapy in patients needing urgent orthopedic surgery is effective and associated with rapid INR reduction and restoration of vitamin K-dependent factors. Compared with plasma, treatment with 4F-PCC also allows patients to undergo surgery earlier. TRIAL REGISTRATION NUMBER: ClinicalTrials. gov identifier, NCT00803101.
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