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Does rFVIIa Play a Role in Traumatic Intracranial Hemorrhage?

The data are promising, but the study was uncontrolled and too small to confirm the value of this treatment.

A large, multicenter, randomized trial presented at the 2007 American Academy of Neurology meeting failed to demonstrate efficacy of recombinant factor VIIa (rFVIIa) for nontraumatic intracranial hemorrhage (not yet published). However, scant attention has been paid to this agent’s potential therapeutic role in traumatic brain injury, particularly in patients with coagulopathy from either anticoagulants or the traumatic intracranial hemorrhage itself. In a prospective observational analysis, researchers at a single level I trauma center report their experience with rFVIIa treatment during 1 year in 15 patients (mean age, 61) with traumatic intracranial hemorrhage and coagulopathy (international normalized ratio >1.3) who needed immediate surgery (defined as presence of at least 1 of 3 features: hematoma diameter >1 cm, midline displacement, or decline in Glasgow Coma Scale score of >2 points or occurrence of seizures or focal neurologic signs).

All patients had subdural hematoma, with concomitant epidural hematoma in two, intracerebral hemorrhage in one, and intracerebral and subarachnoid hemorrhage in one. Patients had a mean admission INR of 2.34; 47% had been taking anticoagulants. After standard treatment with vitamin K (10 patients) and fresh-frozen plasma (15 patients), the mean INR improved to 1.5. At the discretion of the neurosurgeon, rFVIIa (40 or 90 µg/kg) was then administered, resulting in a further decrease of the mean INR to 0.92. Twelve patients underwent successful neurosurgery with good outcomes, and 3 were observed without surgical intervention. No thrombotic complications were reported.

Comment: Recombinant factor VIIa helps activate the extrinsic coagulation pathway and enhances thrombin generation on already activated platelets. In this cohort with traumatic intracranial hemorrhage, after initial treatment with standard reversal agents for coagulopathy, administration of rFVIIa lowered the INR to the preferred operable range, and 20% of patients with planned neurosurgical intervention were subsequently managed nonoperatively. However, the high-grade evidence that failed to demonstrate efficacy presented this year has quelled enthusiasm for use of rFVIIa in nontraumatic intracranial hemorrhage, and, currently, there is no indication for the routine administration of rFVIIa to patients with traumatic intracranial hemorrhage.

— John A. Marx, MD, FAAEM, FACEP

Published in Journal Watch Emergency Medicine November 30, 2007

Citation(s):

Bartal C et al. Coagulopathic patients with traumatic intracranial bleeding: Defining the role of recombinant factor VIIa. J Trauma 2007 Oct; 63:725.

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