Table 2.

Summary of ex vivo and in vivo evidence for reversal of dabigatran anticoagulant effect

Reversal strategy	Animal studies (dabigatran-treated animals)	Ex vivo studies (dabigatran-treated healthy volunteers or patients)	Ex vivo studies (dabigatran-and reversal-agent-treated healthy volunteers)
Nonspecific reversal agents
PCC	No reduction in blood loss after tail transection in mice [18] Reduced intracranial hematoma expansion and 24-hour mortality in mice [19] Reduced blood loss following kidney incision in rabbits [20]	Corrected some TG indices in dabigatran- treated healthy volunteers [14] Corrected PT, aPTT, TT and some TG indices in dabigatran-treated patients [16] No correction of Hemoclot® assay in dabigatran-treated patients [16]	No correction of aPTT, ECT, TT [13]
aPCC	No reduction in blood loss after tail transection in mice [18]	Corrected some TG indices in dabigatran- treated healthy volunteers [14] Corrected PT, aPTT and some TG indices in dabigatran-treated patients [15,16] No correction of Hemoclot® assay in dabigatran-treated patients [16][s10]
rVIIa	No reduction in blood loss after tail transection in mice [18] No reduction in intracranial hematoma expansion and 24-hour mortality in mice [19]	Corrected some TG indices in dabigatran- treated healthy volunteers [14] No correction of PT, aPTT and TG indices in dabigatran-treated patients [16] No correction of Hemoclot® assay in dabigatran-treated patients [16]
Specific reversal agent
Anti-Dabi-Fab [10]	Reduced blood loss after tail transection Corrected dilute PT assay

Abbreviations: Anti-Dabi-Fab, humanized monoclonal antibody fragment against dabigatran; aPCC, activated prothrombin complex concentrate; aPTT, activated partial thromboplastin time; ECT, ecarin clotting time; PCC, prothrombin complex concentrate; PT, prothrombin time; rVIIa, recombinant activated factor VII; TG, thrombin generation; TT, thrombin time.