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Could a clotting protein be the first treatment for bleeding stroke?

NCT ID NCT07227246

Disease control Sponsor: Joseph Broderick, MD Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 21, 2026 · Updated 3 times

Summary

This Phase 3 trial tests whether a clotting drug called recombinant factor VIIa can improve outcomes for people having a hemorrhagic stroke (bleeding in the brain). The drug is given within 2 hours of stroke onset. The study will enroll 350 adults aged 18-80. Half get the drug, half get a placebo, plus standard care. The goal is to see if the drug reduces bleeding and leads to better recovery at 90 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Recombinant factor VIIa (a clotting protein)
What this could lead to
If successful, this could become the first approved treatment for acute hemorrhagic stroke, potentially reducing disability and death.
What could go wrong
This is an early-stage Phase 3 trial with 350 participants. The drug may not improve outcomes or could cause clotting complications. Results may not apply to all stroke patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 350 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 -

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Conditions

The condition(s) this trial relates to.

intracerebral hemorrhage

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Intracerebral hemorrhage

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    89 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Arnau de Vilanova University Hospital

    RECRUITING

    Lleida, Catalonia, 25198, Spain

  • Barnes Jewish Hospital

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Bellvitge University Hospital,

    RECRUITING

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Central DuPage Hospital

    RECRUITING

    Winfield, Illinois, 60190, United States

  • Charite University Medicine Berlin

    RECRUITING

    Berlin, Germany

  • Clinic Frankfurt Hoechst

    RECRUITING

    Frankfurt am Main, Hesse, Germany

  • Gifu University Hospital

    RECRUITING

    Gifu, Japan

  • Girona University Hospital

    RECRUITING

    Girona, Catalonia, 17007, Spain

  • Grady Memorial Hospital

    RECRUITING

    Atlanta, Georgia, 30303, United States

  • Hamilton General Hospital

    RECRUITING

    Hamilton, Ontario, L8L 2X2, Canada

  • Health Sciences Centre Winnipeg

    RECRUITING

    Winnipeg, Manitoba, R3A 1R9, Canada

  • Henry Ford Hospital

    RECRUITING

    Detroit, Michigan, 48208, United States

  • Hospital Universitari Germans Trias i Pujol

    RECRUITING

    Badalona, Barcelona, 21A 08916, Spain

  • Japanese Red Cross Kyoto Daini Hospital

    RECRUITING

    Kyoto, Japan

  • Jichi Medical University Hospital

    RECRUITING

    Shimotsuke, Japan

  • John Radcliffe Hospital

    RECRUITING

    Oxford, Oxfordshire, OX3 9DU, United Kingdom

  • KMU University Hospital

    RECRUITING

    Osaka, Japan

  • Kagoshima City Hospital

    RECRUITING

    Kagoshima, Japan

  • Kaiser Permanente Baldwin Park Medical Center

    RECRUITING

    Baldwin Park, California, 91706, United States

  • Kaiser Permanente Downey Medical Center

    RECRUITING

    Downey, California, 90242, United States

  • Kaiser Permanente Fontana Medical Center

    RECRUITING

    Fontana, California, 92335, United States

  • Kaiser Permanente Los Angeles Medical Center

    RECRUITING

    Los Angeles, California, 90027, United States

  • Kaiser Permanente Riverside Medical Center

    RECRUITING

    Riverside, California, 92505, United States

  • Kaiser Permanente South Bay Medical Center

    RECRUITING

    Harbor City, California, 90710, United States

  • Kaiser Permanente West Los Angeles Medical Center

    RECRUITING

    Los Angeles, California, 90034, United States

  • Kobe City Medical Center General Hospital

    RECRUITING

    Kobe, Japan

  • Kyorin University Hospital

    RECRUITING

    Tokyo, Japan

  • Kyushu Medical Center

    RECRUITING

    Fukuoka, Japan

  • M Health Fairview Ridges Hospital,

    RECRUITING

    Burnsville, Minnesota, 55337, United States

  • M Health Fairview Southdale Hospital

    RECRUITING

    Edina, Minnesota, 55435, United States

  • M Health Fairview St. John's Hospital

    RECRUITING

    Maplewood, Minnesota, 55109, United States

  • M Health Fairview University of Minnesota Medical Center Hospital,

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Saint Marys Campus

    RECRUITING

    Rochester, Minnesota, 55902, United States

  • Medical University of South Carolina University Hospital

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Memorial Hermann Memorial City Medical Center

    RECRUITING

    Houston, Texas, 77024, United States

  • Memorial Hermann-Texas Medical Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Mills Peninsula Medical Center

    RECRUITING

    Burlingame, California, 94010, United States

  • Mount Sinai West

    RECRUITING

    New York, New York, 10019, United States

  • NHO Osaka National Hospital

    RECRUITING

    Osaka, Japan

  • Nakamura Memorial Hospital

    RECRUITING

    Sapporo, Japan

  • National Cerebral and Cardiovascular Center

    RECRUITING

    Suita, Osaka, 564-8565, Japan

  • Niigata City General Hospital

    RECRUITING

    Niigata, Japan

  • North Shore University Hospital

    RECRUITING

    Manhasset, New York, 11030, United States

  • Northwestern Memorial Hospital

    RECRUITING

    Chicago, Illinois, 60611, United States

  • OSU Wexner Medical Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Ottawa Hospital Research Institute

    RECRUITING

    Ottawa, Ontario, K1H 8L6, Canada

  • Prisma Health Greenville Memorial Hospital

    RECRUITING

    Greenville, South Carolina, 29605, United States

  • Providence St. Vincent Medical Center

    RECRUITING

    Portland, Oregon, 97225, United States

  • Queens Medical Centre

    RECRUITING

    Nottingham, United Kingdom

  • Riverside Methodist Hospital

    RECRUITING

    Columbus, Ohio, 43214, United States

  • Ronald Reagan UCLA Medical Center

    RECRUITING

    Los Angeles, California, 90095, United States

  • Royal Stoke University Hospital

    RECRUITING

    Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom

  • Royal Victoria Infirmary

    RECRUITING

    Newcastle upon Tyne, United Kingdom

  • San Francisco General Hospital

    RECRUITING

    San Francisco, California, 94110, United States

  • Santa Creu and Sant Pau Hospital

    RECRUITING

    Barcelona, Catalonia, 08025, Spain

  • St. John Medical Center

    RECRUITING

    Tulsa, Oklahoma, 74104, United States

  • St. Michaels Hospital

    RECRUITING

    Toronto, Ontario, M5B 1W8, Canada

  • Stony Brook University Hospital

    RECRUITING

    Stony Brook, New York, 11794, United States

  • Sunnybrook Health Sciences Center

    RECRUITING

    Toronto, Ontario, M4N 3M5, Canada

  • Temple University Hospital

    RECRUITING

    Philadelphia, Pennsylvania, 19140, United States

  • The Mount Sinai Hospital

    RECRUITING

    New York, New York, 10029, United States

  • The Queen's Medical Center

    RECRUITING

    Honolulu, Hawaii, 96813, United States

  • Toranomon Hospital

    RECRUITING

    Tokyo, Japan

  • UC Davis Medical Center

    RECRUITING

    Sacramento, California, 95817, United States

  • UC Irvine Medical Center,

    RECRUITING

    Orange, California, 92868, United States

  • UCSD Health La Jolla

    RECRUITING

    La Jolla, California, 92037, United States

  • UCSD Medical Center - Hillcrest Hospital

    RECRUITING

    San Diego, California, 92103, United States

  • UF Health Shands Hospital

    RECRUITING

    Gainesville, Florida, 32608, United States

  • UMass Memorial Medical Center

    RECRUITING

    Worcester, Massachusetts, 01605, United States

  • University Hospital Augsburg

    RECRUITING

    Augsburg, 86156, Germany

  • University Hospital Erlangen

    RECRUITING

    Erlangen, Bavaria, 91054, Germany

  • University Hospital Heidelberg

    RECRUITING

    Heidelberg, Baden-Wurttemberg, 69120, Germany

  • University Hospital Tuebingen

    RECRUITING

    Tübingen, 72076, Germany

  • University Medical Center Hamburg

    RECRUITING

    Hamburg, 20246, Germany

  • University of Alabama Hospital

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • University of Alberta Hospital

    RECRUITING

    Edmonton, Alberta, AB T6G 2B7, Canada

  • University of Calgary - Foothills Medical Centre

    RECRUITING

    Calgary, Alberta, Canada

  • University of Chicago Medical Center

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Cincinnati Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • University of Florida Jacksonville (UF Health)

    RECRUITING

    Jacksonville, Florida, 32209, United States

  • University of Montreal Hospital

    RECRUITING

    Montreal, Quebec, H2X 3E4, Canada

  • University of Utah Healthcare

    RECRUITING

    Salt Lake City, Utah, 84132, United States

  • VCU Medical Center

    RECRUITING

    Richmond, Virginia, 23219, United States

  • Vall d'Hebron University Hospital (VHUH)

    RECRUITING

    Horta, Barcelona, Spain

  • Valladolid University Hospital

    RECRUITING

    Valladolid, 47002, Spain

  • Vancouver General Hospital

    RECRUITING

    Vancouver, British Columbia, V5Z 1M9, Canada

  • WellStar Kennestone Hospital

    RECRUITING

    Marietta, Georgia, 30060, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.