Figure 24 references a recent study looking at a  4-factor prothrombin complex concentrate (PCC; Kcentra, CSL Behring GmbH, Marburg, Germany).[16]  The study involved 202 individuals presenting with a warfarin-related major hemorrhage who were assessed over a 24-h period from the start of the PCC infusion.  The study demonstrated a rapid correction of the INR, but found no difference in hemostatic efficacy (although actually this may be  difficult to demonstrate).  There was also no difference in thrombotic events.

Based on this study, in April 2013 the US Food and Drug Administration (FDA) approved this non-activated 4-factor PCC administered for “the urgent reversal of acquired coagulation factor deficiency induced by a vitamin K antagonist (eg, warfarin) therapy in adult patients with acute major bleeding or need for an urgent surgery/invasive procedure.”[17]  For the NOACs, however, there are still no data about the efficacy of PCCs for countering the anticoagulation effect of these agents. Hylek EM. Am J Med 2014; 00.