| Routine management of direct oral anticoagulants (DOACs) asso-ciated bleeding consists of resuscitation and blood component therapy, discontinuation of DOAC therapy, and surgical or local control of bleeding source [1,2]. Results of recently performed studies showed that prothrombin complex concentrate (PCC) may be considered as a therapeutic intervention in bleeding due to DOACs [3,4]. Furthermore, the use of PCCs can interfere with the hemostatic balance and might be associated with thromboembolic events. However, many physicians use PCC for off-label indications like reversal of major bleeding due to DOACs. After obtaining IRB approval and informed written consent from patients or their next of kin, 41 patients with major bleeding due to rivaroxabane were enrolled in this pilot RCT. (https://www.irct.ir. #:IRCT20091012002582N20) The patients had to have taken the last dose of rivaroxaban within 24 h to be included in the study to ensure that the bleeding was related to circulating levels of the anticoagulant in the blood. Exclusion criteria were history of anaphylaxis to PCC, previous usage of anti-platelet drugs or NSAIDs, coagulopathy due to chronic hepatic failure or liver transplantation, previous history of heparin induced thrombocytopenia, thromboembolic events and pa-tients with acute coronary syndrome or ischemic stroke within the past 30 days. All patients with major bleeding due to rivaroxabane were managed with standard criteria for initial resuscitation, blood component therapies and discontinuation of rivaroxaban. In FFP group patients received 10–15 ml/kg fresh frozen plasma for management of bleeding and in PCC group patients received 25–50 IU/Kg PCC (Octaplex, Octapharma Canada). In the case of ongoing bleeding, patients in group F received 7 ml/kg additional dosage of FFP and those in group P re-ceived 25 IU/Kg additional PCC for management of bleeding. The as-sessment of effectiveness was continuously done throughout the study by the number of units required for transfusion. Demographic char-acteristics of patients and occurrence of any thrombotic complications are shown in Table 1. Our results showed that units of transfused packed cell in FFP group was significantly more than PCC group (p < 0.001). (Table 1) Regarding the effects of confounding factors on bleeding amount using multiple logistic regression analysis, our results showed a significant effect for APACHE score, duration of rivaroxaban use, management of bleeding (FFP vs. PCC) (Table 1). |