Comparison of three-factor and four-factor prothrombin complex concentrates regarding reversal of the anticoagulant effects of rivaroxaban in healthy volunteers

摘要: Summary Background Four-factor prothrombin complex concentrates (PCCs), which contain factor II, FVII, FIX, and FX, have shown the potential to reverse anticoagulant effect of rivaroxaban in healthy volunteers. The purpose this study was determine whether a three-factor PCC, contains little has similar effect. Methods results We performed an open-label, single-center, parallel-group comparing PCC (Profilnine SD) with that four-factor (Beriplex P/N) on pharmacodynamics 35 After receiving 4 days 20 mg twice daily obtain supratherapeutic steady-state concentrations, volunteers were randomized receive single 50 IU kg−1 bolus dose or saline 4 h after morning day 5, effects these interventions time thrombin generation determined. Within 30 min, reduced mean by 2.5–3.5 s, whereas produced only 0.6–1.0-s reduction. In contrast, reversed rivaroxaban-induced changes more than PCC. Conclusions This demonstrates both PCCs at least partially adults. discrepant preparations may reflect differences procoagulant components present each.