Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care
Overview of rFVIIa for Bleeding Secondary to Brain Trauma
Research yielded low strength of evidence with fair applicability for treatment use in the population targeted—patients with intracranial hemorrhage secondary to TBI who were not on anticoagulation therapy.
Regarding the benefits and harms of rFVIIa, our findings include:
·There was no effect of rFVIIa on mortality or thromboembolic event rate. ·rFVIIa use vs. usual care had no effect on hematoma growth but, in the one study that evaluated it, reduced the time to neurosurgical intervention (e.g., by normalizing the INR to an acceptable level). ·Current evidence of low strength is too limited to compare harms and benefits.
Regarding subpopulations of patients, our findings include:
·Patients with coagulopathy may have increased benefits. ·Patients experiencing blunt trauma to the cerebral vessels may have a greater risk of thromboembolic events when rFVIIa is used.
- Narayan RK, Maas AI, Marshall LF, et al. Recombinant factor VIIA in traumatic intracerebral hemorrhage: results of a dose-escalation clinical trial. Neurosurgery 2008;62:776-786.
- Stein DM, Dutton RP, Kramer ME, et al. Recombinant factor VIIa: decreasing time to intervention in coagulopathic patients with severe traumatic brain injury. J Trauma 2008;64:620-7.
- Yank V, Tuohy CV, Logan AC, et al. Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care, Comparative Effectiveness Review 21 (Prepared by Stanford–UCSF Evidence-based Practice Center under Contract No. 290-02-0017). Rockville, MD: Agency for Healthcare Research and Quality; May 2010. AHRQ Publication No. 10-EHC030-EF.
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