Safety and efficacy of a prothrombin complex concentrate in patients with coagulopathy and hemorrhage

Background. Prothrombin complex concentrates (FCC) are approved for urgent reversal of vitamin K antagonists (VKA). Recently, FCC have been used in the management of massive bleeding-associated coagulopathy. The present work evaluates safety and efficacy of FCC in a case series of both VKA reversal and massive bleeding. Methods. Retrospective review of cases treated with CCP (January 2010 to February 2013). Safety endpoints were infusion reactions and incidence of thromboembolic events. Efficacy endpoints were: 1) VKA reversal efficacy and 2) Massive bleeding coagulopathy reversal and 24h mortality. Results. Thirty-one patients were included (22 male), median age 61 years (range 30-86). No infusion reactions were detected, and only 1 thrombotic episode was observed. VKA reversal was effective in 100% of patients (6/6), all of them with complete reversal of INR value. In massive bleeding, 24-hour survival was 64% (16/25). Invasive hemostatic procedures were required in 28% of patients (7/25). CCP use was correlated with bleeding control in 44% of cases (11/25), and also significantly associated with survival (p=0.01). Conclusion. CCP are safe and effective for the novel indication of adjuvant treatment in massive bleeding patients, as well as for traditional urgent reversal of VKA.