The efficacy of factor VIIa in emergency department patients with warfarin use and traumatic intracranial hemorrhage.

OBJECTIVES: The objective was to compare outcomes in emergency department (ED) patients with preinjury warfarin use and traumatic intracranial hemorrhage (tICH) who did and did not receive recombinant activated factor VIIa (rFVIIa) for international normalized ratio (INR) reversal.

METHODS: This was a retrospective before-and-after study conducted at a Level 1 trauma center, with data from 1999 to 2009. Eligible patients had preinjury warfarin use and tICH on cranial computed tomography (CT) scan. Patients before (standard cohort) and after (rFVIIa cohort) implementation of a protocol for administering 1.2 mg of rFVIIa in the ED were reviewed. Glasgow Coma Scale (GCS) score, Revised Trauma Score (RTS), Injury Severity Score (ISS), INR, and Marshall score were collected. Outcome measures included mortality, thromboembolic complications, and INR normalization.

RESULTS: Forty patients (median age=80.5 years, interquartile range [IQR]=63.5-85) were included (20 in each cohort). Age, GCS score, ISS, RTS, initial INR, and Marshall score were similar (p>0.05) between the two cohorts. Survival was identical between cohorts (13 of 20, or 65.0%, 95% confidence interval [CI]=40.8% to 84.6%). There were no differences in rate of thromboembolic complications in the standard cohort (1 of 20, 5.0%, 95% CI=0.1% to 24.9%) than the rFVIIa cohort (4 of 20, 20.0%, 95% CI=5.7% to 43.7%; p=0.34). Time to normal INR was earlier in the rFVIIa cohort (mean=4.8 hours, 95% CI=3.0 to 6.7 hours) than in the standard cohort (mean=17.5 hours, 95% CI=12.5 to 22.6; p<0.001).

CONCLUSIONS: In patients with preinjury warfarin and tICH, use of rFVIIa was associated with a decreased time to normal INR. However, no difference in mortality was identified. Use of rFVIIa in patients on warfarin and tICH requires further study to demonstrate important patient-oriented outcomes.