Background: In 2010, the U.S. Food and Drug Administration (FDA) approved dabigatran as the first non-warfarin oral anticoagulant for use in the United States. At the time of FDA approval, there was no antidote or effective treatment for dabigatran-induced hemorrhage. In 2015, the FDA approved idarucizumab for the treatment of dabigatran-induced hemorrhage. The purpose of this clinical practice statement is to evaluate the role of select reversal agents in the management of patients with dabigatran-associated bleeding.
Methods: A PubMed literature review was completed to identify studies that investigated the role of reversal agents in the management of emergency department patients with dabigatran-associated hemorrhage. Articles included were those published in the English language between January 2010 and January 2017, enrolled human subjects, and limited to the following types: randomized controlled trials, prospective trials, meta-analyses, and retrospective cohort studies. Review articles, case series, and case reports were not included in this review. All selected articles then underwent a structured review by the authors.
Results: Six hundred fifty-two articles were identified in the search. After use of predetermined inclusion and exclusion criteria, six articles were selected for structured review.
Conclusion: The clinical efficacy of activated prothrombin complex concentrates, idarucizumab, and recombinant factor VIIa remains unclear until further research is performed. Activated prothrombin complex concentrates, idarucizumab, and recombinant factor VIIa may be considered in patients with serious bleeding from dabigatran, after careful consideration of possible benefits and risks.
Keywords: anticoagulation; dabigatran; factor eight inhibitor bypass activity; fresh frozen plasma; life-threatening hemorrhage; prothrombin complex concentrates; recombinant factor VIIa; severe hemorrhage.
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