Recombinant factor VIIa given very early for bleeding stroke
FVIIa for Acute hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial
['FUNDING_U01'] · UNIVERSITY OF CINCINNATI · NIH-11473255
This trial gives a clotting medicine called rFVIIa very soon after a spontaneous brain bleed to adults to try to improve recovery.
Quick facts
| Phase | ['FUNDING_U01'] |
|---|---|
| Study type | Nih_funding |
| Sex | All |
| Sponsor | UNIVERSITY OF CINCINNATI (nih funded) |
| Locations | 1 site (CINCINNATI, UNITED STATES) |
| Trial ID | NIH-11473255 on ClinicalTrials.gov |
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.
Who could benefit from this research
Good fit: 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.
Not a fit: 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.
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 performed: 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
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.