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

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