Warfarin-reversal: results of a phase III study with pasteurised, nanofiltrated prothrombin complex concentrate

Bleeding can be a major problem in patients on oral anticoagulation therapy. Beriplex P/N is a prothrombin complex concentrate (PCC) that has been developed for the rapid reversal of anticoagulation in patients requiring immediate haemostatic control. Beriplex P/N contains high concentrations of the coagulation factors II, VII, IX and X, together with the inhibitors protein C and protein S, and it can be rapidly prepared and administered at an infusion rate of up to 8.0 mL/min. The efficacy of Beriplex P/N in patients requiring emergency reversal of oral anticoagulation has been demonstrated in a prospective, open-label, uncontrolled study involving 43 patients; 17 with acute bleeding and 26 requiring emergency surgery. Beriplex P/N was administered at a dose of 25-50 IU/kg, according to baseline international normalised ratio (INR) in conjunction with vitamin K. Mean INR 30 minutes post-infusion was 1.18, and 93% of patients achieved an INR of