Findings from this randomized clinical trial demonstrated that the investigational 4-factor prothrombin complex concentrate (4F-PCC) is statistically noninferior to the control 4F-PCC for rapid reversal of vitamin K antagonists (VKAs) in patients at substantial risk for bleeding during urgent surgeries. Effective hemostasis was achieved in 94.3% of patients receiving the investigational 4F-PCC compared to 94.2% with the control. Safety profiles were comparable, with no significant differences in thrombotic events or mortality rates.
Multicenter Study by Sarode R, Goldstein JN (…) Milling TJ et 4 al. in JAMA Netw Open