Early Factor VIIa treatment for bleeding stroke
Official title: FVIIa for Acute hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial
Funded at University of Cincinnati · NIH-11473147 · Data updated 2026-11-12
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 start | March 1, 2020 |
| Project end | December 31, 2026 |
| Funding year | 2026 |
| Award (this year) | $389,840 |
| NIH project number | 3U01NS110772-05S1 |
| Project ID | NIH-11473147 on NIH RePORTER |
Who could benefit from this research
✓Could help
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.
✕Less likely to help
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.
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.
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 gone: 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
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University of Cincinnati
Cincinnati, United States Active
Researchers
- Principal investigator: Broderick, Joseph Paul — University of Cincinnati
- Study coordinator: Broderick, Joseph Paul
Related research
Other NIH-funded projects on the same topics.
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Cross-talk between SARM1-driven axon damage and ferroptosis in brain hemorrhage
A study in people with brain bleeding (intracerebral hemorrhage) to understand how axons get damaged and how iron-related cell death contributes to disability.
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Recombinant factor VIIa given very early for bleeding stroke
This trial gives a clotting medicine called rFVIIa very soon after a spontaneous brain bleed to adults to try to improve recovery.
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Early clotting-factor treatment for sudden brain bleed
This research gives a clotting medicine called rFVIIa very soon after a sudden brain bleed to see whether people with intracerebral hemorrhage do better than with standard care alone.
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Ultrasound method to safely treat brain bleeds without open surgery
A new ultrasound-based technique aims to liquefy and drain intracerebral hemorrhage through the skull in a minimally invasive way.
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Early Factor VIIa treatment for bleeding stroke
This research compares early intravenous recombinant Factor VIIa plus usual care with usual care alone for people who have a sudden brain bleed (intracerebral hemorrhage) to try to improve recovery.
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Ultrasound method to break up and drain brain clots from bleeding strokes
Using focused ultrasound through the skull to liquefy and drain blood clots for people with intracerebral hemorrhage (bleeding stroke).
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.