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Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial

Trial for rFVIIa treatment in hemorrhagic stroke patients.

Recruiting
18-80 years
All
Phase 3
  • Simplified description (AI rewritten)
  • Technical description (Original)

The FASTEST Trial is studying a new treatment for a type of stroke called intracerebral hemorrhage (ICH), which is when bleeding happens inside the brain. The trial is testing a drug called recombinant Factor VIIa (rFVIIa) to see if it helps patients recover better than standard treatment. Participants must be treated within 120 minutes of the stroke starting. The study will happen in hospitals and mobile stroke units across several countries, including the U.S., Canada, and the U.K. The trial will last 3½ years and aims to include 860 participants.

Eligibility: Adults aged 18 to 80 with spontaneous ICH can join if treated within 120 minutes of stroke onset. You cannot participate if your stroke is due to known causes like trauma or certain medications, or if you have other specific health conditions.

  • Study Duration: 180-day follow-up, with check-ins at 30 and 90 days.
  • Treatment: Randomized to receive either rFVIIa or a placebo, plus standard care.
  • Compensation: Not specified, but participants undergo regular health assessments.
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Study details
    Intracerebral Hemorrhage

NCT03496883

Joseph Broderick, MD

12 October 2024

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