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Using rFVIIa to treat hemorrhagic stroke

Recombinant Factor VIIa (rFVIIa) for Acute Hemorrhagic Stroke Administered At Earliest Time (FASTEST) Trial

Phase 3 Interventional University of Cincinnati · NCT03496883

This study is testing if a new treatment called rFVIIa can help people who have had a bleeding stroke feel better when given quickly after the stroke happens.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment860 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorUniversity of Cincinnati Academic / other
Locations89 sites (Birmingham, Alabama and 88 other locations)
Trial IDNCT03496883 on ClinicalTrials.gov

What this trial studies

The FASTEST Trial aims to evaluate the effectiveness of recombinant Factor VIIa (rFVIIa) in patients with acute spontaneous intracerebral hemorrhage (ICH) when administered within 120 minutes of stroke onset. This Phase III trial will randomly assign participants to receive either rFVIIa or a placebo, alongside best standard therapy, to assess outcomes at 180 days using the Modified Rankin Score (mRS). The study will involve approximately 860 participants across 100 hospital sites and mobile stroke units in multiple countries, utilizing emergency research informed consent procedures to expedite treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with spontaneous ICH who can be treated within 120 minutes of stroke onset.

Not a fit: Patients with secondary ICH, severe pre-existing disability, or those who cannot be treated within the specified time frame may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients suffering from acute hemorrhagic strokes.

How similar studies have performed: Previous studies have shown promise with similar approaches, but this specific application of rFVIIa in acute ICH is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Patients aged 18-80 years, inclusive
2. Patients with spontaneous ICH
3. Able to treat with study medication (rFVIIa/placebo) within 120 minutes of stroke onset or last known well
4. Efforts to obtain informed consent per EFIC guidelines (U.S.) or adherence to country-specific emergency research informed consent regulations (Canada, Germany, Spain, U.K., Japan)

Exclusion Criteria:

1. Score of 3 to 7 on the Glasgow Coma Scale
2. Secondary ICH related to known causes (e.g., trauma, aneurysm, arteriovenous malformation (AVM), oral anticoagulant use (vitamin K antagonists or novel oral anticoagulants) within the past 7 days, coagulopathy, etc.)
3. ICH volume \< 2 cc or ≥ 60 cc
4. Blood filling 2/3 or more of one lateral ventricle of the brain, OR, blood filling at least 1/3 of both lateral ventricles.
5. Pre-existing disability (mRS \> 2)
6. Symptomatic thrombotic or vaso-occlusive disease in past 90 days (e.g., cerebral infarction, myocardial infarction, pulmonary embolus, deep vein thrombosis, or unstable angina)
7. Clinical or EKG evidence of ST elevation consistent with acute myocardial ischemia
8. Brainstem location of hemorrhage (patients with cerebellar hemorrhage may be enrolled)
9. Refusal to participate in study by patient, legal representative, or family member
10. Known or suspected thrombocytopenia (unless current platelet count documented above 50,000/μL)
11. Unfractionated heparin use with abnormal PTT
12. Pro-coagulant drugs within 24 hours prior to patient enrollment into the FASTEST trial (example, tranexamic acid or aminocaproic acid)
13. Low-molecular weight heparin use within the previous 24 hours
14. Recent (within 90 days) carotid endarterectomy or coronary or cerebrovascular angioplasty or stenting
15. Advanced or terminal illness or any other condition the investigator feels would pose a significant hazard to the patient if rFVIIa were administered
16. Recent (within 30 days) participation in any investigational drug or device trial or earlier participation in any investigational drug or device trial for which the duration of effect is expected to persist until to the time of FASTEST enrollment
17. Planned withdrawal of care or comfort care measures
18. Patient known or suspected of not being able to comply with trial protocol (e.g., due to alcoholism, drug dependency, or psychological disorder)
19. Known or suspected allergy to trial medication(s), excipients, or related products
20. Contraindications to study medication
21. Previous participation in this trial (previously randomized)
22. Females of childbearing potential who are known to be pregnant or within 12 weeks post-partum and/or lactating at time of enrollment

Where this trial is running

Birmingham, Alabama and 88 other locations

+39 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Intracerebral Hemorrhage
Last reviewed 2026-06-15 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.