Lancet

ISC 2026: Recombinant factor VIIa slows bleeding in intracerebral hemorrhage but not disability

February 5, 2026

In the multicenter, double‑blind, randomized FASTEST trial (NCT03496883), 626 adults with acute spontaneous intracerebral hemorrhage (ICH) received either recombinant factor VIIa (80 μg/kg) or placebo within 2 hours of stroke onset. The study was stopped early for futility after an interim analysis. Although recombinant factor VIIa was associated with reduced ICH growth at 24 hours, functional outcomes at 180 days didn't differ between groups (adjusted common odds ratio, 1.09; 95% confidence interval [CI], 0.79–1.51; p=0.61). Serious thromboembolic events within the first four days were reported in 15 participants in the rFVIIa group (under 5%) compared with four participants (1%) receiving placebo, corresponding to a relative risk of 3.41 (95% CI, 1.14–10.15; p=0.020). Investigators highlighted that patients treated within 90 minutes and those with CT angiography “spot signs” demonstrated signals of improved outcomes and the largest reduction in hematoma growth observed to date. These exploratory subgroup findings will guide the next phase of the study. Results were presented at the International Stroke Conference on February 4.

Clinical takeaway: For now, rFVIIa does not improve global functional outcomes in spontaneous ICH, but clinicians should note that ultra‑early treatment (<90 min) and spot‑sign–positive patients may represent promising subgroups for future therapy.

Source:

Broderick JP, et al. (2026, February 4). Lancet. Recombinant factor VIIa versus placebo for spontaneous intracerebral haemorrhage within 2 h of symptom onset (FASTEST): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. https://www.sciencedirect.com/science/article/abs/pii/S0140673626000978