The use of recombinant factor VIIa in warfarin patients with traumatic brain injury: a retrospective case-control study.

Patients on warfarin who have traumatic intracranial haemorrhage have a high mortality. The procoagulant recombinant factor VIIa (rFVIIa) is widely used off-label to treat intracranial haemorrhaging in patients taking warfarin to try to improve these adverse outcomes, but its effectiveness is unknown. In this study, medical records from 2002 to 2010 were reviewed for 27 warfarin patients who received rFVIIa for their traumatic intracranial haemorrhage and were compared with a matched control group of 27 warfarin patients who did not receive rFVIIa. The two groups were matched for sex, age and Injury Severity Score. The rFVIIa patients had 33.3% mortality compared with the 37% for the control patients, but this was not a statistically significant difference. There was also no significant difference in plasma unit use between the groups. However, the rFVIIa group had a significantly higher number of subdural haemorrhages, which carry a better prognosis. The initial international normalized ratios (INRs) of the rFVIIa patients were higher, and the decrease of INR was more pronounced than in the control patients. From the data, it appears that although the INRs of rFVIIa patients did improve compared with the control group, there was no reduction in plasma use or mortality.