Analysis of 11 consecutive patients who developed intracranial hemorrhage during warfarin therapy with PT-INR less than 2.0 and antidoted with administration of 4-factor prothrombin complex concentrate

Introduction: For patients with acute intracranial hemorrhage during warfarin therapy, there is no guideline for the use of 4-factor prothrombin complex concentrate (4F-PCC) at a PT-INR less than 2.0. Purpose/Methods: We retrospectively investigated the appropriate dose of 4F-PCC in 11 consecutive patients with intracranial hemorrhage, 8 with intracerebral hemorrhage and the other 3 with acute subdural hematoma. Results: The median PT-INR before and after administration of 4F-PCC was 1.80 (range 1.49–1.93), and 1.13 (range 1.03–1.42), respectively. In nine patients with PT-INR < 1.30 after administration, median 19.1 IU/kg (14.5–23.8) of the 4F-PCC was given while in the other two patients with PT-INR was 1.42 and 1.30 after correction, 4F-PCC of 10.5 and 19.5 IU/kg were administered, respectively. Hematoma enlargement was observed in 2 cases with PT-INR < 1.30 after correction. No thromboembolism occurred after the 4F-PCC administration. No deaths were observed. Conclusions: It seems that 4F-PCC of 14.5–23.8 IU/kg is safe and effective to achieve PT-INR < 1.30 in patients with intracranial hemorrhage during warfarin therapy and PT-INR < 2.0.