Recombinant factor VIIa treatment for acute intracerebral hemorrhage

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Alabama Hospital
  Birmingham, Alabama, United States Recruiting
• Kaiser Permanente Baldwin Park Medical Center
  Baldwin Park, California, United States Recruiting
• Mills Peninsula Medical Center
  Burlingame, California, United States Recruiting
• Kaiser Permanente Downey Medical Center
  Downey, California, United States Recruiting
• Kaiser Permanente Fontana Medical Center
  Fontana, California, United States Recruiting
• Kaiser Permanente South Bay Medical Center
  Harbor City, California, United States Recruiting

+38 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Joseph P Broderick — University of Cincinnati
• Study coordinator: Joseph P Broderick, MD
• Email: broderjp@ucmail.uc.edu
• Phone: 15139195404

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.