Early clotting-factor treatment for sudden brain bleed
Official title: FVIIa for Acute hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial
Funded at University of Cincinnati · NIH-11473146 · Data updated 2026-11-12
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.
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) | $72,275 |
| NIH project number | 3U01NS110772-05S2 |
| Project ID | NIH-11473146 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates are adults age 80 or younger with spontaneous intracerebral hemorrhage under 60 cc, little or no intraventricular blood, a Glasgow Coma Scale score of at least 8, and who can be treated within 120 minutes of symptom onset.
✕Less likely to help
Patients with very large hemorrhages, extensive intraventricular bleeding, severe coma (GCS <8), those treated beyond the two-hour window, or with other exclusionary conditions are unlikely to benefit and would not be eligible.
What this research studies
If you have a sudden intracerebral hemorrhage (a spontaneous brain bleed), this study randomly gives patients either the clotting medicine recombinant Factor VIIa (rFVIIa) plus standard care or a placebo plus standard care. Treatment must be started extremely quickly—within 120 minutes of when you were last known to be normal—with a goal that many patients receive treatment within 90 minutes using participating hospitals and mobile stroke units. The trial plans to enroll about 860 patients at roughly 100 hospital sites worldwide and is double-blind so neither patients nor clinicians know who gets the drug. Strict inclusion rules (smaller bleed volume, limited or no intraventricular bleeding, age ≤80, and GCS ≥8) are used and the study allows emergency exception from informed consent to avoid delaying treatment.
Why it matters
Potential benefit: If successful, giving rFVIIa very early could limit bleeding and reduce long-term disability after an intracerebral hemorrhage.
How similar studies have gone: Previous rFVIIa trials reduced hematoma growth but did not show clear overall clinical benefit and raised safety concerns, so this trial tests whether much earlier treatment in selected patients improves 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
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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 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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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.