Idarucizumab (PRADAXA®) as a sole reversal agent in an unstable hemorrhagic shock patient on an unknown anticoagulant with elevated protime/international normalized ratio (PT/INR).

Published:February 05, 2021DOI:


      Dabigatran is a direct oral anticoagulant thrombin inhibitor approved for stroke prophylaxis in patients with non-valvular atrial fibrillation and prophylaxis or treatment of venous thromboembolism. Since approval, there has been increasing concern regarding bleeding risk, predominantly in the elderly population and those with renal disease.
      We present a case of an 85-year-old female with an unknown medication history, shortness of breath and severe anemia due to an upper gastrointestinal bleed. Laboratory abnormalities were significant for INR 6.43 and serum creatinine 2.21 mg/dL. While in the emergency department the patient decompensated requiring intubation, aggressive crystalloid resuscitation, blood products and initiation of vasopressors. The inability to distinguish between warfarin- and dabigatran-induced coagulopathies paired with the lack of medical information complicated selection of the appropriate anticoagulation reversal agent. In an attempt to prevent a prothrombotic state, prothrombin complex concentrates (PCC) were held and reversal was accomplished with idarucizumab alone, although warfarin-induced coagulopathy remained a possibility. 30 min after administration, repeat PT/INR was 16.1 s and 1.55, respectively. It was later confirmed that the patient was on sole dabigatran therapy.
      This case highlights the potential for dabigatran to cause extreme elevation in PT/INR in patients with acute renal failure, which may mimic warfarin-induced coagulopathy. Further, it demonstrates significant, rapid correction of abnormal coagulation assays following administration of idarucizumab in a patient with severe INR elevation and suspected dabigatran use.


      To read this article in full you will need to make a payment
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to The American Journal of Emergency Medicine
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Ganetsky M.
        • Babu K.M.
        • Salhanick S.D.
        • Brown R.S.
        • Boyer E.W.
        Dabigatran: review of pharmacology and management of bleeding complications of this novel oral anticoagulant.
        J Med Toxicol. 2011 Dec; 7: 281-287
      1. Idarucizumab [package insert]. Boehringer Ingelheim, Ridgefield, CTOctober 2015
        • Burnett A.E.
        • Mahan C.E.
        • Vazquez S.R.
        • Oertel L.B.
        • Garcia D.A.
        • Ansell J.
        Guidance for the practical management of the direct oral anticoagulants (DOACs) in VTE treatment.
        J Thromb Thrombolysis. 2016 Jan; 41: 206-232
        • Kim J.
        • Yadava M.
        • Chul An I.
        • et al.
        Coagulopathy and extremely elevated PT/INR after dabigatran etexilate use in a patient with end-stage renal disease.
        Case Rep Med. 2013; 2013: 1-4
        • Sarma A.
        • Rossi J.E.
        • Connors J.M.
        • Giugliano R.P.
        Dabigatran excess: case report and review of the literature.
        Cardiol Ther. 2013; 2: 111-124
        • Maddry J.K.
        • Amir M.K.
        • Sessions D.
        • Heard K.
        Fatal dabigatran toxicity secondary to acute renal failure.
        Am J Emerg Med. 2013; 31 (462e1–462.e2)
        • Jones J.M.
        • Ryan H.M.
        • Tieszen M.
        • Leedahl D.D.
        Successful hemostasis and reversal of highly elevated PT/INR after dabigatran etexilate use in a patient with acute kidney injury.
        Am J Emerg Med. 2016 Apr; 34 (758.e5–6)
        • Steele A.P.
        • Lee J.A.
        • Dager W.E.
        Incomplete dabigatran reversal with idarucizumab.
        Clin Toxicol (Phila). 2018 Mar; 56: 216-218
        • Memon W.
        • Aamir M.
        • Memon A.
        Extremely elevated international normalized ratio in a patient with dabigatran etexilate use.
        Cureus. 2019; 11 (Published 2019 Jun 15)e4906
        • Woo J.S.
        • Kapadia N.
        • Phanco S.E.
        • Lynch C.A.
        Positive outcome after intentional overdose of dabigatran.
        J Med Toxicol. 2013 Jun; 9: 192-195
        • Eerenberg E.S.
        • Kamphuisen P.W.
        • Sijpkens M.K.
        • Meijers J.C.
        • Buller H.R.
        • Levi M.
        Reversal of rivaroxaban and dabigatran by prothrombin complex concentrate: a randomized, placebo-controlled, crossover study in healthy subjects.
        Circulation. 2011; 124: 1573-1579
        • Grottke O.
        • et al.
        Efficacy of prothrombin complex concentrates for the emergency reversal of dabigatran-induced anticoagulation.
        Crit Care. 2016; 20 (27125504): 115
        • Honickel M.
        • Braunschweig T.
        • Rossaint R.
        • et al.
        Reversing dabigatran anticoagulation with prothrombin complex concentrate versus idarucizumab as part of multimodal hemostatic intervention in an animal model of polytrauma.
        Anesthesiology. 2017; 127: 852-861