"We were able to reduce bleeding, but that wasn't enough to improve patients' long‑term outcomes,"
"Any medication that enhances clotting will carry a thrombotic risk. What we still need to determine is whether there's a subgroup where the bleeding risk is so high that the potential benefit outweighs that danger."
A global randomized trial across 93 hospitals in six countries enrolled more than 600 patients with spontaneous intracerebral hemorrhage. Participants were randomly assigned to receive recombinant factor VIIa or an identical placebo, with all doses administered within two hours of symptom onset. Functional outcomes measured by the modified Rankin Scale at 180 days showed no difference between groups. Brain imaging demonstrated significantly slower growth of intracerebral and intraventricular hemorrhages with recombinant factor VIIa. Life-threatening thromboembolic events occurred in 15 treated patients versus four in the placebo group, indicating increased clotting risk without long-term functional benefit.
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