Human recombinant factor VII for emergency reversal of coagulopathy in neurosurgical patients: a retrospective comparative study.

OBJECTIVE: Severe coagulopathy in a neurosurgical patient with intracranial hemorrhage is a common and serious problem. Current therapy with vitamin K and fresh-frozen plasma (FFP) may be too slow in certain situations. There are reports of rapid reversal of coagulopathy using human recombinant factor VII. We present a retrospective controlled study of our experience with factor VII.

METHODS: We used factor VII as a second-line therapy after initial attempts at reversal with FFP had failed. Factor VII was given to 29 patients in the neurosurgical intensive care unit; 24 patients treated before the introduction of factor VII were control subjects. The groups were matched by age, sex, cause of coagulopathy, and presence of intracranial hemorrhage.

RESULTS: After initial FFP administration, the international normalized ratio (INR) changed from a mean of 2.57 to 1.67 in the factor VII group and from 2.17 to 1.85 in control subjects. In all patients, INR tended to rebound. Before administration of factor VII, the mean INR was 2.206. After 1.4 mg of factor VII, mean INR decreased to 1.12 (P < 0.05). Measured from admission, INR in the factor VII group normalized within 6.78 +/- 2.68 hours, and in control subjects, within 47.44 +/- 9.88 hours (P < 0.0005). Six factor VII patients and six control subjects died. The number of patients with good functional outcome (Glasgow Outcome Scale score of 5) was greater among patients treated with factor VII compared with those who received only vitamin K and FFP (nine versus two, P = 0.04). None of the deaths were the result of a thrombotic complication. There were no thrombotic complications in the factor VII group.

CONCLUSION: Factor VII is safe and highly effective when emergency reversal of coagulopathy is desired and may improve the functional outcome. We speculate that the use of factor VII as first choice may result in decreased use of FFP and thus increase patient safety.