Randomized Trialhigh evidence

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.

Lancet (London, England)·February 21, 2026·PMID 41653933

Why it matters

This large phase 3 trial confirms that early hemostatic therapy with factor VIIa reduces hematoma expansion but does not translate into better functional recovery, while increasing thromboembolic risk. It reinforces the need for caution in using factor VIIa outside of trials and highlights the disconnect between imaging endpoints and clinical outcomes.

Infographic summary of 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.
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