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Table 4 Clinical studies investigating the use of PCCs and aPCCs to reverse dabigatran-induced anticoagulation

From: Efficacy of prothrombin complex concentrates for the emergency reversal of dabigatran-induced anticoagulation

Reference Study design Dose Main results Conclusion
   Dabigatran (mg) PCC (IU/kg)   
Eerenberg et al., 2011 [59] Randomised, placebo-controlled crossover (study included rivaroxaban and dabigatran) 150 50 (administered to healthy volunteers) 50 IU/kg PCC did not correct aPTT, thrombin-generation lag time, TT or ECT PCC did not neutralise the anticoagulant effect of dabigatran
Marlu et al., 2012 [60] Ex vivo, randomised crossover (study included rivaroxaban and dabigatran) 150 PCC (in vitro): 12.5, 25 or 50aPCC (in vitro): 20, 40 or 80 PCC restored changes in ETP at all three doses Some non-specific reversal agents appear able to reverse the anticoagulant activity of dabigatran
     aPCC corrected both ETP and lag time at doses of 40 and 80 U/kg but not 20 U/kg  
Herrmann et al., 2014 [48] Ex vivo, cohort study of patients receiving dabigatran for non-valvular atrial fibrillation 150 PCC (in vitro): 500 mU/mlaPCC (in vitro): 500 mU/ml Dabigatran prolonged aPTT, PT, TT, dynamic parameters of TEG® and ROTEM® and thrombin-generation lag time; it also reduced ETP and thrombin-generation peak height Some non-specific reversal agents appear able to reverse the anticoagulant activity of dabigatran
     All parameters ameliorated by aPCC  
     All parameters except PT ameliorated by PCC  
  1. aPCC activated prothrombin complex concentrate, aPTT activated partial prothrombin time, ECT ecarin clotting time, ETP endogenous thrombin potential, PCC prothrombin complex concentrate, PT prothrombin time, TT thrombin time