Early Factor VIIa treatment for bleeding stroke
FVIIa for Acute hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial
This project tests whether giving a clotting medicine called recombinant Factor VIIa very soon after a spontaneous brain bleed helps adults recover better than standard care alone.
Quick facts
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | University of Cincinnati NIH-funded |
| Lab location | 1 site (Cincinnati, United States) |
| Project ID | NIH-11473147 on NIH RePORTER |
What this research studies
If you have a spontaneous intracerebral hemorrhage (a non-traumatic brain bleed), this study would randomly give you either recombinant Factor VIIa or a placebo in addition to standard treatment, with neither you nor your care team knowing which you receive. The trial aims to treat patients within two hours of symptom onset and enrolls adults up to age 80 with smaller bleeds and little or no blood in the brain ventricles. It is randomized, double-blind, and will recruit about 860 patients at roughly 100 hospitals and at least 15 mobile stroke units across several countries. The study measures recovery using standard disability scales at 90 days after the bleed.
Who could benefit from this research
Good fit: Ideal candidates are adults (age ≤80) with a spontaneous intracerebral hemorrhage under about 60 cc, minimal or no intraventricular bleeding, Glasgow Coma Scale ≥8, and who can be treated within 120 minutes of last being normal at a participating site or mobile stroke unit.
Not a fit: Patients with very large bleeds, extensive intraventricular hemorrhage, very low consciousness, traumatic brain bleeds, or those who cannot receive treatment within two hours are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the treatment could limit bleeding growth and improve functional recovery after an intracerebral hemorrhage, reducing disability.
How similar studies have performed: Earlier trials of recombinant Factor VIIa showed it can reduce early bleeding growth but did not clearly improve long-term outcomes, so this earlier-treatment, larger trial aims to test whether faster treatment changes that result.
Where this research is happening
Cincinnati, United States
- University of Cincinnati — Cincinnati, United States (Active)
Researchers
- Principal investigator: Broderick, Joseph Paul — University of Cincinnati
- Study coordinator: Broderick, Joseph Paul
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.