Intracerebral Hemorrhage study: Recombinant Factor VIIa
Official title Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial - Part 2
ClinicalTrials.gov ID: NCT07227246
What this study is testing
What is Recombinant Factor VIIa?
An investigational biological medicine being studied as a potential treatment for acute intracerebral hemorrhage. It is designed to activate the clotting cascade and promote blood clot formation to stop bleeding.
Also referred to as NovoSeven, NiaStase.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether giving a clotting drug early after a brain bleed helps people recover better. It looks at people who have a special sign on their first CT scan or who get the drug very quickly.
- Who it's for
- You may be able to join if you have a sudden brain bleed and can get to the hospital within 2 hours of symptoms.
- What's involved
- You would receive the drug through a vein in your arm. You will have a few visits to the hospital and some blood tests to check how well the drug works and if it causes any problems.
- Time commitment
- The study lasts about 90 days after the bleed, with visits at the hospital soon after treatment and later check‑ins to see how you are doing.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Patients aged 18-80 years, inclusive
- Patients with spontaneous ICH
- 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...
- Efforts to obtain informed consent per EFIC guidelines (U.S.) or adherence to country-specific emergency research informed consent regulations...
You likely can't join if
- Score of 3 to 7 on the Glasgow Coma Scale
- Secondary ICH related to known causes (e.g., trauma, aneurysm, arteriovenous malformation (AVM), oral anticoagulant use (vitamin K antagonists or...
- ICH volume \< 2 cc or ≥ 60 cc
- Blood filling 2/3 or more of one lateral ventricle of the brain, OR, blood filling at least 1/3 of both lateral ventricles.
- Pre-existing disability (mRS \> 2)
- Symptomatic thrombotic or vaso-occlusive disease in past 90 days (e.g., cerebral infarction, myocardial infarction, pulmonary embolus, deep vein...
See the full eligibility criteria
- Patients aged 18-80 years, inclusive
- Patients with spontaneous ICH
- 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...
- 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)
- Score of 3 to 7 on the Glasgow Coma Scale
- 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.)
- ICH volume \< 2 cc or ≥ 60 cc
- Blood filling 2/3 or more of one lateral ventricle of the brain, OR, blood filling at least 1/3 of both lateral ventricles.
- Pre-existing disability (mRS \> 2)
- Symptomatic thrombotic or vaso-occlusive disease in past 90 days (e.g., cerebral infarction, myocardial infarction, pulmonary embolus, deep vein thrombosis, or unstable angina)
- Clinical or EKG evidence of ST elevation consistent with acute myocardial ischemia
- Brainstem location of hemorrhage (patients with cerebellar hemorrhage may be enrolled)
- Refusal to participate in study by patient, legal representative, or family member
- Known or suspected thrombocytopenia (unless current platelet count documented above 50,000/μL)
- Unfractionated heparin use with abnormal PTT
- Pro-coagulant drugs within 24 hours prior to patient enrollment into the FASTEST trial (example, tranexamic acid or aminocaproic acid)
- Low-molecular weight heparin use within the previous 24 hours
- Recent (within 90 days) carotid endarterectomy or coronary or cerebrovascular angioplasty or stenting
- Advanced or terminal illness or any other condition the investigator feels would pose a significant hazard to the patient if rFVIIa were administered
- 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...
- Planned withdrawal of care or comfort care measures
- Patient known or suspected of not being able to comply with trial protocol (e.g., due to alcoholism, drug dependency, or psychological disorder)
- Known or suspected allergy to trial medication(s), excipients, or related products
- Contraindications to study medication
- Previous participation in this trial (previously assigned by chance)
- Females of childbearing potential who are known to be pregnant or within 12 weeks post-partum and/or lactating at time of enrollment -
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Baldwin Park, California, United States
- Burlingame, California, United States
- Downey, California, United States
- Fontana, California, United States
- Harbor City, California, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- Riverside, California, United States
- Sacramento, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Gainesville, Florida, United States
- Jacksonville, Florida, United States
- Atlanta, Georgia, United States
- Marietta, Georgia, United States
- Honolulu, Hawaii, United States
- Chicago, Illinois, United States
- Winfield, Illinois, United States
+ 58 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Baldwin Park, California, United States; Burlingame, California, United States; Downey, California, United States; Fontana, California, United States; Harbor City, California, United States and 72 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.