[Articles] 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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Source: The Lancet

Original: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(26)00097-8/fullt...

Published: 2026-02-04T17:57:01Z

The FASTEST study was a phase 3, multicenter, double-blind, randomized, placebo-controlled trial. It investigated recombinant factor VIIa versus placebo in patients with spontaneous intracerebral hemorrhage (ICH) administered within 2 hours of symptom onset. Recombinant factor VIIa slowed the growth of hematomas. However, it did not improve the patients' functional outcomes. The treatment showed a slightly increased risk of life-threatening thromboembolic complications. Further testing of recombinant factor VIIa in patients at greatest risk of continued bleeding is ongoing.