Effects of recombinant activated factor VII in traumatic nonsurgical intracranial hemorrhage

OBJECTIVE: To determine whether treatment with recombinant activated factor VII (rFVIIa) will prevent progression of bleeding in nonsurgical hemorrhagic traumatic brain injury (TBI). METHODS: Chart review from the trauma registry of a level 1 trauma center between January 1, 2002 and December 31, 2004 identified 2 patients who received rFVIIa for progressive hemorrhagic TBI. These patients were given a single dose of rFVIIa (120 mcg/kg) after a repeat head computed tomography (CT) scan showed worsening of intracranial bleeding. Pre-rFVIIa and post-rFVIIa coagulation parameters and postintervention CT scans were performed. A matched convenience sample was drawn from the institution's trauma registry reflecting similar injury patterns. RESULTS: The 2 patients who received rFVIIa were ages 61 and 79 years; the patients in the matched convenience sample were 57 and 63 years. Both sets of patients comprised 1 man and 1 woman who had suffered blunt trauma, including hemorrhagic TBI, and were matched according to age, gender, and injury severity score (ISS). During their hospital course, repeat CT scans documented worsening of intracranial hemorrhage in both cohorts. In the rFVIIa patients, follow-up CT showed overall improvement of head injury compared with the convenience sample. The rFVIIa patients also saw an appreciable decrease in both prothrombin time (PT) and international normalized ratio (INR). CONCLUSIONS: In hemorrhagic TBI, rFVIIa has the potential to limit or even halt the progression of bleeding that would otherwise place growing pressure on the brain. A prospective, randomized multicenter trial is planned to elucidate this hypothesis.