NIH-funded research U01 cooperative agreement

Using a blood clotting factor to treat acute brain bleeding quickly

Official title: FVIIa for Acute hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial

Funded at University of Cincinnati · NIH-11014938 · Data updated 2026-11-12

This study is looking at whether giving a special medication called rFVIIa to people who have a sudden brain bleed can help them recover better when it's given quickly, along with regular treatment, and it involves 860 patients from different countries.

Quick facts

Grant typeU01 cooperative agreement
Study typeNIH-funded research
Funding institutionUniversity of Cincinnati
NIH-funded
Lab location1 site (Cincinnati, United States)
Project startMarch 1, 2020
Project endDecember 31, 2026
Funding year2025
Award (this year)$4,412,639
NIH project number5U01NS110772-04
Project IDNIH-11014938 on NIH RePORTER

Who could benefit from this research

Could help

Ideal candidates are individuals aged 80 or younger who have experienced a spontaneous intracerebral hemorrhage and can be treated within two hours of symptom onset.

Less likely to help

Patients with larger volumes of hemorrhage or those with significant intraventricular hemorrhage may not benefit from this research.

What this research studies

This research investigates the use of recombinant Factor VIIa (rFVIIa) in patients experiencing acute intracerebral hemorrhage (ICH). The trial aims to determine if administering rFVIIa within two hours of symptom onset, alongside standard treatment, can improve patient outcomes compared to standard treatment alone. The study will involve 860 patients across multiple countries and will utilize mobile stroke units to expedite treatment. Participants will be monitored for their recovery over 90 days using a standardized scale.

Why it matters

Potential benefit: If successful, this research could significantly improve recovery outcomes for patients suffering from acute brain hemorrhages.

How similar studies have gone: Previous studies have shown promising results with similar approaches in treating acute strokes, indicating potential for success in this trial.

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.

    NIH research Suny Downstate Medical Center · Brooklyn, United States · NIH-11600981

  • 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.

    NIH research University of Cincinnati · Cincinnati, United States · NIH-11473255

  • 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.

    NIH research University of Cincinnati · Cincinnati, United States · NIH-11473147

  • 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.

    NIH research University of Cincinnati · Cincinnati, United States · NIH-11473146

  • 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.

    NIH research University of Michigan at Ann Arbor · Ann Arbor, United States · NIH-11379522

  • 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.

    NIH research University of Cincinnati · Cincinnati, United States · NIH-11286770

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.