British journal of haematology
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In an open non-randomized study, 10 patients with major bleeding and an Internationalized Normal Ratio (INR) greater than 14 were treated with 5 mg of intravenous vitamin K and 30 iu/kg of a single concentrate containing factors II, VII, IX and X (Beriplex P/N; Aventis Behring). The levels of these factors before and immediately after treatment were 4.7, 1.6, 8.5 and 1.1 iu/dl and 94, 30, 66 and 91 iu/dl respectively. The median INR before treatment was greater than 20 and, after treatment, 1.1. All patients had a satisfactory clinical response with immediate cessation of bleeding, and no thromboembolic complications occurred.