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Recombinant factor VIIa treatment for acute intracerebral hemorrhage

Recombinant Factor VIIa (rFVIIa) for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial - Part 2

Phase 3 Interventional University of Cincinnati · NCT07227246

This trial will try recombinant factor VIIa in adults with spontaneous intracerebral hemorrhage to see if very early treatment reduces bleeding and improves 90‑day outcomes.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment350 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorUniversity of Cincinnati Academic / other
Locations89 sites (Birmingham, Alabama and 88 other locations)
Trial IDNCT07227246 on ClinicalTrials.gov

What this trial studies

FASTEST Part 2 is a global Phase III, randomized, double-blind, placebo-controlled trial comparing rFVIIa plus best standard therapy versus placebo plus best standard therapy in adults with spontaneous intracerebral hemorrhage. It enrolls patients aged 18–80 with ICH volume 2 to <60 cc, limited intraventricular hemorrhage, and Glasgow Coma Scale ≥8 who can be treated within 120 minutes with a positive CTA spot sign or within 90 minutes regardless of spot sign. To minimize time to treatment the protocol uses emergency research consent pathways (including EFIC in the U.S.) and mobile stroke units, targeting about half of participants treated within 90 minutes, and plans roughly 350 participants across ~100 hospitals and at least 15 MSUs worldwide. Primary outcomes include 90‑day functional outcome measured by the Modified Rankin Scale and imaging measures of ongoing bleeding/hematoma expansion.

Who should consider this trial

Good fit: Ideal candidates are adults 18–80 with spontaneous ICH measuring 2–<60 cc, limited ventricular blood, GCS ≥8, and who can receive study drug within 120 minutes with a positive CTA spot sign or within 90 minutes regardless of spot sign.

Not a fit: Patients with very large hemorrhages (≥60 cc) or very small bleeds (<2 cc), secondary causes of ICH (e.g., trauma, aneurysm, AVM), recent oral anticoagulant use, severe coma (GCS 3–7), or extensive intraventricular hemorrhage are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, this approach could reduce hematoma expansion and meaningfully improve 90‑day functional outcomes for a selected group of very early‑treated ICH patients.

How similar studies have performed: Previous rFVIIa trials reduced hematoma growth but did not show clear overall clinical benefit, though FASTEST Part 1 suggested that very early, biomarker‑selected subgroups may derive benefit, so this Phase III effort builds on promising but not definitive prior data.

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 with a positive spot sign on pretreatment CT angiography or treatment within 90 minutes with or without spot sign.
4. Efforts to obtain informed consent per EFIC guidelines (U.S.) or adherence to country-specific emergency research informed consent regulations (Canada, Germany, Spain, Finland, U.K., Japan, Australia)

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 HemorrhageIntracerebral hemorrhagerecombinant factor VIIa
Last reviewed 2026-06-13 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.