The USFDA recently approved prothrombin complex concentrate for the urgent reversal of vitamin K antagonist-induced coagulation factor deficiency in adult patients indicated for emergent surgeries and invasive procedures. This drug restores the levels of blood clotting factors reduced due to warfarin treatment. The clotting factors contained in an inactivated form in the prothrombin derivative are Factor II, Factor IX, Factor X, and antithrombotic Proteins C and S.
A phase III, randomized, double-blinded, and multicenter trial was performed at 24 sites in the US and Europe on 208 patients on warfarin treatment indicated for surgeries or invasive procedures. The prothrombin complex concentrate met the primary endpoint of achieving hemostatic efficacy in 94.6% of patients compared to the 93.5% of patients who received the comparator drug. Drug details Do you think prothrombin complex…
