Trial reportResearch and practice in thrombosis and haemostasis2026
High-dose four-factor prothrombin complex concentrate for vitamin K antagonist reversal before urgent surgery: subanalysis of the LEX-209 randomized, active-controlled trial.
Trial report in Research and practice in thrombosis and haemostasis, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02740335 (A Phase III, Randomized, Double-blind, Multicenter Study to Assess the Efficacy and Safety of OCTAPLEX, a Four-factor Prothrombin Complex Concentrate), which is not on this map. Not yet cited in PubMed.
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A Phase III, Randomized, Double-blind, Multicenter Study to Assess the Efficacy and Safety of OCTAPLEX, a Four-factor Prothrombin Complex Concentrate (4F-PCC), Compared to the 4F-PCC Beriplex® P/N (Kcentra), for the Reversal of Vitamin K Antagonist (VKA) Induced Anticoagulation in Patients Needing Urgent Surgery With Significant Bleeding Risk.
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7 authors.
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Abstract
Background: Four-factor prothrombin complex concentrates (4F-PCCs) reverse vitamin K antagonist (VKA)-induced acquired coagulation factor deficiency. However, limited data exist on the benefits and risks of 4F-PCC treatment in patients with supratherapeutic international normalized ratio (INR) values (>6), for whom a high dose of 4F-PCC (50 IU/kg) is indicated. Objective: To assess the hemostatic efficacy and safety of high-dose 4F-PCC in patients on VKA therapy before urgent surgery with an INR > 6. Methods: The LEX-209 Phase 3 randomized, active-controlled study (NCT02740335) enrolled adults taking VKAs before urgent surgery with a substantial bleeding risk. Patients were randomized to either investigational or control 4F-PCC. This post hoc subanalysis included patients with baseline INR > 6, who were given high-dose 4F-PCC (50 IU/kg). Outcomes were analyzed according to original treatment assignment. The primary endpoint was hemostatic efficacy assessed by a blinded Independent Endpoint Adjudication Board. Results: Twenty-three patients had an INR > 6 (mean ± SD INR, 9.1 ± 3.2). The mean ± SD dose of 4F-PCC administered was similar in the investigational ( Conclusions: In this small sample, 4F-PCC, at the maximum permitted dose, was effective for VKA reversal in patients requiring urgent surgery, with no adverse safety signal observed.
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