Recombinant factor VIIa given very early for bleeding stroke
Official title: FVIIa for Acute hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial
Funded at University of Cincinnati · NIH-11473255 · Data updated 2026-11-12
This trial gives a clotting medicine called rFVIIa very soon after a spontaneous brain bleed to adults to try to improve recovery.
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) | $50,000 |
| NIH project number | 3U01NS110772-05S3 |
| Project ID | NIH-11473255 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults (≤80 years) with spontaneous intracerebral hemorrhage who present within 120 minutes of symptom onset, have ICH volume under 60 cc, limited or no intraventricular hemorrhage, and a Glasgow Coma Scale score of 8 or higher are the intended candidates.
✕Less likely to help
Patients with very large hemorrhages, severe depressed consciousness (GCS <8), extensive intraventricular bleeding, very late presentation, or contraindications to the drug are unlikely to benefit or may be ineligible.
What this research studies
If you have a spontaneous intracerebral hemorrhage (bleeding in the brain), this randomized, double‑blind trial may give you either rFVIIa plus standard care or a placebo plus standard care. The team aims to treat patients within 120 minutes of when they were last seen normal, with a goal of half treated within 90 minutes using participating hospitals and mobile stroke units. The study enrolls adults up to age 80 with smaller bleeds (under 60 cc), little or no intraventricular blood, and a Glasgow Coma Scale of 8 or higher, and follows recovery at 90 days using standard disability scales. About 860 patients across roughly 100 sites worldwide will be randomized to test whether very early treatment changes outcomes.
Why it matters
Potential benefit: If successful, early rFVIIa treatment could limit bleeding in the brain and improve the chances of better recovery after intracerebral hemorrhage.
How similar studies have gone: Previous trials found rFVIIa can reduce hematoma growth but did not show clear functional benefit, so this earlier, targeted trial tests whether much faster treatment can change outcomes.
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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Early Factor VIIa treatment for bleeding stroke
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.
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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.