Abstract

MARTINEZ-CALLE, N. et al. Safety and efficacy of a prothrombin complex concentrate in patients with coagulopathy and hemorrhage. Anales Sis San Navarra [online]. 2014, vol.37, n.3, pp.363-369. ISSN 1137-6627.  https://dx.doi.org/10.4321/S1137-66272014000300006.

Background: Prothrombin complex concentrates (PCC) are approved for urgent reversal of vitamin K antagonists (VKA). Recently, PCC have been used in the management of massive bleeding-associated coagulopathy. The present work evaluates safety and efficacy of PCC 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.

Keywords : Prothrombin complex concentrates; Massive hemorrhage; Oral anticoagulant reversal; Safety; Thrombosis.

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