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-11286770 · Data updated 2026-11-12
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.
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) | $2,875,758 |
| NIH project number | 5U01NS110772-05 |
| Project ID | NIH-11286770 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults 18–80 with a spontaneous intracerebral hemorrhage under 60 cc, minimal or no intraventricular hemorrhage, Glasgow Coma Scale ≥8, and who can be treated within 120 minutes of last known normal.
✕Less likely to help
People with very large bleeds, significant intraventricular hemorrhage, age over 80, low consciousness (GCS <8), or those who arrive more than two hours after symptom onset are not eligible and are unlikely to benefit.
What this research studies
If I arrive at a participating hospital or mobile stroke unit within two hours of a sudden brain bleed and meet the study criteria, I could be randomly given an IV dose of recombinant Factor VIIa or a placebo in addition to usual treatment. The trial is double-blind, aims to treat many patients within 90 minutes, and plans to enroll about 860 people across roughly 100 sites worldwide. The study uses strict eligibility (small-to-moderate bleed size, limited or no ventricular bleeding, age 80 or younger, and GCS ≥8) to select people most likely to benefit. Researchers will compare recovery at 90 days using a standard disability scale and will use exception from informed consent in some emergency settings to speed treatment.
Why it matters
Potential benefit: If successful, earlier Factor VIIa treatment could reduce bleed expansion and improve recovery after intracerebral hemorrhage.
How similar studies have gone: Previous trials found rFVIIa could limit hematoma growth but did not show better long-term outcomes, so this much-earlier treatment strategy is novel and unproven.
Where this research is happening
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.