Key result
Prothrombin complex concentrate completely reversed the prothrombin time prolongation induced by rivaroxaban (12.8 vs 15.8 seconds; P<0.001) but did not reverse the anticoagulant action of dabigatran.
Why the study?
Does prothrombin complex concentrate reverse the anticoagulant effects of rivaroxaban and dabigatran in healthy male volunteers?
Population
12 healthy male volunteers
Comparison
Single bolus of 50 IU/kg prothrombin complex… vs Similar volume of saline (placebo)
Design
RCT, randomized, double-blind, placebo-controlled
Follow-up
Immediate (after single bolus)
Authors
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PCC reverses rivaroxaban but not dabigatran; provides first RCT evidence for targeted reversal while leaving clinical bleeding outcomes open.
RCT (n=12)
double-blind
randomized
Does prothrombin complex concentrate reverse the anticoagulant effects of rivaroxaban and dabigatran in healthy male volunteers?
Absolute Event Rate: 12.8% vs 15.8%
p-value: p=<0.001
Prothrombin complex concentrate effectively reverses the anticoagulant effects of the factor Xa inhibitor rivaroxaban, but not the direct thrombin inhibitor dabigatran, providing a potential emergency reversal strategy for specific NOACs.
Eerenberg et al. (2011) conducted an RCT in Healthy (n=12). Prothrombin complex concentrate (PCC) vs. Saline was evaluated on prothrombin time (p=<0.001). Prothrombin complex concentrate completely reversed the prothrombin time prolongation induced by rivaroxaban (12.8 vs 15.8 seconds; P<0.001) but did not reverse the anticoagulant action of dabigatran.
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