Update in Neurology

Stroke

Recombinant Activated Factor VIIa Helped Patients with Acute Intracerebral Hemorrhage

Intracerebral hemorrhage is one of the least treatable forms of stroke, and it primarily affects patients with hypertension. Continued bleeding is thought to occur in many patients with intracerebral hemorrhage (1), and the condition is associated with neurologic deterioration and high mortality rates. Administering early hemostatic therapy to patients with intracerebral hemorrhage in the emergency department might improve outcomes by stopping ongoing bleeding and minimizing increases in the volume of the hematoma.

In their manufacturer-supported, randomized, controlled trial, Mayer and colleagues compared 3 doses of recombinant activated factor VIIa (rFVIIa) (a hemostatic agent used to treat bleeding in patients with hemophilia) with placebo in patients with intracerebral hemorrhage. They randomly assigned 399 patients to receive 40 µg of rFVIIa per kg of body weight (n = 108), 80 µg/kg of rFVIIa (n = 92), 160 µg/kg of rFVIIa (n = 103), or placebo (n = 96) within 4 hours of intracerebral hemorrhage onset. The primary outcome was the percentage change in the volume of the intracerebral hemorrhage at 24 hours. They assessed measures of neurologic impairment and functional outcome at 90 days.

Overall, the investigators found that patients treated with rFVIIa had a smaller increase in hematoma volume (estimated mean absolute increase in volume from baseline, 4.2 mL [98.3% CI, 2.0 to 6.3 mL]) than those who received placebo (8.7 mL [98.3% CI, 4.9 to 12.4 mL]; P = 0.01). The effect seemed attributable to the 2 higher doses of rFVIIa. Fewer patients in the treatment groups died or were severely disabled compared with those in the placebo group (absolute reduction, 16% [95% CI, 5% to 27%]; P = 0.004). The main adverse …