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Background  Direct oral anticoagulants (DOACs) pose a great challenge for physicians in life-threatening bleeding events. The aim of this study was to test the efficacy of reversing the DOAC rivaroxaban using four-factor PCC (prothrombin complex concentrate), a non-specific reversing agent.    Methods  Patients with life-threatening bleeding events during rivaroxaban treatment were included and administered 25 U kg −1  of PCC. Blood samples were collected immediately prior to as well as after PCC treatment at predefined time intervals. The primary endpoint was defined as the difference in thrombin generation (TG) parameters ETP (endogenous thrombin potential) and C max  (peak thrombin generation) prior to and ten minutes subsequent to PCC treatment.    Results  Thirteen patients, of whom the majority suffered from intra-cranial haemorrhage (ICH) or subdural haemorrhage (SDH), were included and administered PCC. The results show that the ETP (TG) significantly ( p  = 0.001) improved by 68% and C max  (TG) by 54% (p = 0.001) during PCC treatment. In addition, the Quick value (prothrombin time: Quick PT ) significantly improved by 28% and the activated partial thromboplastin time (aPTT) was decreased by 7% ten minutes after PCC administration. C max  was reduced at baseline, but not ETP, aPTT or Quick PT . Lag time until initiation (TG, t lag ), thromboelastometry clotting time (CT EXTEM ) and time to peak (TG, t max ) correlated best with measured rivaroxaban levels and were out of normal ranges at baseline, but did not improve after PCC administration. In 77% of the patients bleeding (ICH/SDH-progression) ceased following PCC administration. During the study three participants passed away due to other complications not related to PCC treatment. The possibility of thrombosis formation was also evaluated seven days after administering PCC and no thromboses were found.    Conclusions  This study shows that use of PCC improved ETP, C max,  Quick PT  and aPTT. However, of these parameters, only C max  was reduced at the defined baseline. It can be concluded that CT EXTEM,  t lag  and t max  correlated best with the measured rivaroxaban levels. The study drug was found to be safe. Nonetheless, additional studies specifically targeting assessment of clinical endpoints should be performed to further confirm these findings.    Clinical trial registration  EudraCT trial No.  2013–004484-31 .    Electronic supplementary material  The online version of this article (10.1186/s12959-017-0158-9) contains supplementary material, which is available to authorized users.

thrombosis journal

Four-factor prothrombin complex concentrate improves thrombin generation and prothrombin time in patients with bleeding complications related to rivaroxaban: a single-center pilot trial