452

Abstract

Introduction: It is unclear if administering a 3-factor prothrombin complex concentrate (PCC) with or without fresh frozen plasma (FFP) reverses the international normalized ratio (INR) faster than FFP alone in patients with warfarin-associated intracranial hemorrhage (ICH). Methods: This was an IRB approved retrospective cohort study of adult patients with warfarin-associated ICH and an INR>1.5 who received Profilnine with or without FFP versus FFP alone. Results: Of the 68 patients who met criteria, 32 patients were included in the PCC group and 36 patients were included in the FFP only group. The time to reversal of the INR to ≤1.5 from admission to a hospital was 11.3 hours in the PCC group and 15.4 hours in the FFP group (p=0.023). The time to reversal from treatment administration was 4.2 hours in the PCC group and 9.1 hours in the FFP group (p=0.001). In patients with a pre-treatment INR<3, the mean PCC dose was 34 IU/kg and the time to reversal was 9.2 hours for the PCC group and 15.7 hours for the FFP group (p=0.001). In patients with a pre-treatment INR >3, the mean PCC dose was 34–41 IU/kg and there was no significant difference between groups in time to reversal of the INR. A greater percentage of patients in the PCC group than in the FFP group had an INR ≤1.3 at 24 hours (91% vs 58%, p=0.03). In-hospital mortality was 22% for the PCC group and 8% for the FFP only group (p=0.17). There were 9 patients with documented pulmonary edema after treatment in the FFP only group versus 4 patients in the PCC group (p=0.75). There were 3 thrombotic events documented after PCC treatment (9%). Conclusions: This study demonstrated that a 3-factor PCC administered with FFP corrected the INR faster than FFP alone in patients with warfarin-associated ICH. When stratified by pre-treatment INR, PCC reversed the INR faster for patients with an INR<3, but not for patients with an INR>3. This may be explained by the lower than recommended average PCC dose administered to patients with an INR>4. Significantly more patients in the PCC group had an INR ≤1.3 at 24 hours than in the FFP group.