• Prothrombin Complex Concentrate (PCC) Kcentra™ has been approved for urgent reversal of major bleeding in patients taking vitamin K antagonists (e.g. warfarin).

• It contains factors 2,7,9 and 10, and antithrombotic Proteins C and S.

• Both fatal and non-fatal arterial and venous thromboembolic complications have occurred with Kcentra™. Thrombotic events occurred more frequently in the PCC group compared to plasma, although the differences were not statistically significant.

• Volume overload occurred less frequently in the PCC group, as there is a smaller volume  administered with PCC compared to that of plasma.

• Percentage of INR ≤ 1.3 at 30 minutes was 62% in the PCC group and 9.6% in the plasma group.

Approval of Kcentra™ may open the door for studying treatment of the bleeding patient on newer oral anticoagulants.