Clinical outcomes after 4F-PCC for warfarin-associated ICH and baseline GCS less than or equal to 8.

Purpose: There is limited evidence describing the mortality benefit of utilizing 4-factor prothrombin complex concentrate (4F-PCC) in patients presenting with a warfarin-associated intracerebral hemorrhage (ICH) and a Glasgow Coma Scale (GCS) of ≤8. The aim of this study is to determine the potential mortality benefit of 4F-PCC in this patient population.

Methods: This was a retrospective chart review, performed at a comprehensive stroke center from October 2013 through August 2020. Patients were included if they were ≥ 18 years of age, experienced a spontaneous ICH with baseline GCS ≤ 8, treated with warfarin prior to admission, had a baseline INR ≥ 1.7, and received 4F-PCC for INR normalization due to warfarin-associated ICH. The primary outcome was in-hospital mortality at 30 days.

Results: A total of 252 patients received 4F-PCC in the specified time period. Of those patients, 25 patients met inclusion criteria. Sixteen patients (64%) experienced in-hospital mortality. When compared to a historical estimated 80% mortality rate in the studied patient population, there was no statistically significant difference (p = 0.208) in mortality when 4F-PCC was utilized to reverse INR.

Conclusion: The administration of 4F-PCC in patients presenting with warfarin-related ICH and GCS ≤ 8 did not result in statistically significant mortality benefit. Our results are limited by study design and sample size. Thus, larger studies are needed to determine if a benefit exists for 4F-PCC in this patient population. Although the results are not statistically significant, our small study suggests that there may be a clinically significant mortality benefit when 4F-PCC is utilized.