title: Treatment of dabigatran-associated bleeding: case report and review of the literature.
abstract: Dabigatran etexilate is a competitive, direct thrombin inhibitor that works in the coagulation cascade to ultimately prevent thrombus formation. It is recommended by the 2012 American College of Chest Physicians evidence-based clinical practice guidelines as first-line therapy over vitamin k antagonists for long-term antithrombotic therapy in patients with paroxysmal or persistent nonrheumatic atrial fibrillation who are at intermediate to high risk of stroke and systemic embolism (grade 2B). However, serious postmarketing events involving life-threatening bleeding are emerging with no antidote for reversal of the anticoagulant effect being available for use. Potential reversal agents are being used in clinical practice with questionable efficacy and safety profiles. We report a case involving an 84-year-old male with acute kidney injury who developed life-threatening gastrointestinal and surgical site bleeding secondary to dabigatran accumulation. Use of the Naranjo probability scale indicated a probable cause between the bleeding event and dabigatran use. After discontinuation of drug therapy, fresh frozen plasma, recombinant coagulation factor VIIa, and cryoprecipitate were administered as potential reversal agents with negligible benefit. However, this patient appeared to slowly benefit with administration of continuous venovenous hemodialysis. Based upon our experience with this patient and literature review, the most effective treatment algorithm for dabigatran-associated bleeding may be to utilize hemodialysis initially.
authors.affiliation: Department of Pharmacy, Cleveland Clinic, Cleveland, OH, USA. harinsl@ccf.org
authors.forename: Lisa M
authors.initials: LM
authors.lastname: Harinstein
authors.forename: Joseph W
authors.initials: JW
authors.lastname: Morgan
authors.forename: Nicholas
authors.initials: N
authors.lastname: Russo
mesh_terms: D000369:Aged, 80 and over; D000465:Algorithms; D000991:Antithrombins / Q000008:administration & dosage / Q000009:adverse effects*; D001562:Benzimidazoles / Q000009:adverse effects*; D000069604:Dabigatran; D005169:Factor VIII / Q000008:administration & dosage; D015942:Factor VIIa / Q000008:administration & dosage; D005340:Fibrinogen / Q000008:administration & dosage; D006471:Gastrointestinal Hemorrhage / Q000139:chemically induced / Q000628:therapy; D006470:Hemorrhage / Q000139:chemically induced / Q000628:therapy*; D006801:Humans; D008297:Male; D010949:Plasma; D011725:Pyridines / Q000009:adverse effects*; D006435:Renal Dialysis / Q000379:methods; D016896:Treatment Outcome
chemical_list: D000991:Antithrombins; D001562:Benzimidazoles; D011725:Pyridines; C026912:cryoprecipitate coagulum; D005169:Factor VIII; D005340:Fibrinogen; D015942:Factor VIIa; D000069604:Dabigatran