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

An Sist Sanit Navar. 2014 Sep-Dec;37(3):363-9. doi: 10.4321/s1137-66272014000300006.
[Article in Spanish]

Abstract

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.

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Blood Coagulation Disorders / drug therapy*
  • Blood Coagulation Factors / therapeutic use*
  • Female
  • Hemorrhage / drug therapy*
  • Humans
  • Male
  • Middle Aged
  • Retrospective Studies
  • Treatment Outcome

Substances

  • Blood Coagulation Factors
  • prothrombin complex concentrates