Low-dose recombinant factor VIIa for reversing coagulopathy in patients with isolated traumatic brain injury

Abstract

Purpose: The purpose of this study was to investigate the role of low-dose recombinant factor VIIa (rFVIIa) (20 μg/kg) in reversing coagulopathy in patients with isolated traumatic brain injury (TBI).

Materials and methods: Patients with isolated TBI and coagulopathy at admission were enrolled prospectively from January 2010 to December 2011. The patients were divided into 2 groups: the rFVIIa and the no-rFVIIa groups. In the rFVIIa group, patients received a single dose of 20 μg/kg rFVIIa intravenously to reverse their coagulopathy in addition to blood products. Patients in the no-rFVIIa group received only blood products to correct the coagulopathy. The clinical outcome variables evaluated included changes in coagulation parameters after administration for reversing coagulopathy, the occurrence of progressive hemorrhagic injury (PHI), intensive care unit length of stay, the incidence of thromboembolic complications, inhospital mortality, and 90-day Glasgow Outcome Scale.

Results: Eighty-seven patients were ultimately included in this study. Of them, 49 patients were treated with blood products alone, whereas 38 patients also received rFVIIa to reverse their coagulopathy. The improvement in international normalized ratio was greater in the rFVIIa group (0.26 [0.18-0.39]) than in the no-rFVIIa group (0.06 [-0.11 to 0.30]) (P = .001). In addition, the improvement in lactate was also greater in the rFVIIa group (0.33 [-0.18 to 0.54]) than in the no-rFVIIa group (0.04 [-0.25 to 0.20]) (P = .029). During the period after we began to correct the coagulopathy, PHI occurred in 19 patients (38.8%) in the no-rFVIIa group, which was significantly higher than that in the rFVIIa group (7, 18.4%; P = .040). The rate of cerebral infarction was similar in both groups (10.2% vs 5.3%). There was a trend indicating that low-dose rFVIIa therapy was associated with a lower mortality, but the association was not statistically significant (P = .266).

Conclusions: The use of low-dose rFVIIa (20 μg/kg) is effective for correcting coagulopathy in patients with TBI without an increase in thromboembolic events. Moreover, it is more effective for preventing the occurrence of PHI.

Keywords: Coagulopathy; Recombinant factor VIIa; Traumatic brain injury.