Background: Since 2012, factor Xa inhibitors (FXai) have been widely used in Thailand, however, no specific reversal agent including four-factor prothrombin complex concentrate is available in Thailand so far. Therefore, three-factor prothrombin complex concentrate (3F-PCC) has been used to reverse the action of FXai. Nevertheless, the clinical efficacy of 3F-PCC to reverse FXai had been reported in a few small case series.

Aims: To assess the effectiveness of 3F-PCC in major bleeding associated with FXai as primary outcome. And secondary outcome is to determine the use of blood component, duration of hospitalization, mortality and thrombotic event within 30 days after 3F-PCC administration.

Methods: We conducted a retrospective review of using 3F-PCC in patients with major bleeding associated with factor Xa Inhibitor at Siriraj hospital from January 2012 to December 2019.

Results: Ten patients (median age 73 years, range 60 to 83; 5 men) who were treated with 3F-PCC for reversal of FXai (7 rivaroxaban, 3 apixaban) were identified. The indications for using 3F-PCC included gastrointestinal bleeding (7 cases), intraperitoneal bleeding (one case), trauma-related bleeding (one case) and emergency surgery (one case). 3F-PCC were mostly given at emergency department (60%). Dose of 3F-PCC were 50 units/kg (70%), 75 units/kg (20%), and 25 units/kg (10%). There were 8/10 (80%) patients receiving fresh frozen plasma. According to ISTH criteria, the outcome of all patients was rated as effective and no thrombotic event or death occurred during 30 days.

Conclusions: In Thailand, 3F-PCC might be an effective and safe nonspecific reversal agent for major bleeding associated with factor Xa Inhibitor especially in gastrointestinal bleeding.

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ISTH Congress Abstracts - https://abstracts.isth.org/abstract/clinical-outcome-of-using-three-factor-prothrombin-complex-concentrate-in-patients-with-major-bleeding-associated-with-factor-xa-inhibitor/