Recombinant Factor VII for Patients with Intracerebral Hemorrhage

Highly selected patients with ICH benefited from rFVIIa, but these results must be balanced against the drug's thromboembolic risks and high cost.

Recombinant activated factor VII (rFVIIa; trade name, NovoSeven) is FDA-approved for use in patients with hemophilia A or B who have inhibitors to factors VIII and IX. However, the drug has also been used -- in both practice settings and small trials -- for bleeding patients in other clinical circumstances. In this industry-supported, international randomized trial, researchers examined whether rFVIIa improves outcomes in patients with intracerebral hemorrhage.

The trial involved 399 patients with spontaneous intracerebral hemorrhage documented by computed tomographic scans within 3 hours of symptom onset. Patients received single injections of rFVIIa (at doses of 40, 80, or 160 μg/kg) or placebo within 1 hour after diagnosis. According to r…

Reviewing Author

Allan S. Brett, MD