Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial

Launched by JOSEPH BRODERICK, MD · Apr 5, 2018

Keywords

ClinConnect Summary

The rFVIIa for Hemorrhagic Stroke Trial is a research study aimed at finding a new treatment for patients who have experienced a type of stroke called intracerebral hemorrhage, which is bleeding inside the brain. The goal is to see if a medication called recombinant Factor VIIa (rFVIIa) can help improve recovery when given within two hours of the stroke starting. Researchers believe that this medication might reduce bleeding and enhance recovery, measured by how well patients can function 180 days after treatment.

To participate in the trial, individuals need to be between 18 and 80 years old and have had a sudden intracerebral hemorrhage. They must be able to receive the study medication within 120 minutes of their stroke. However, there are certain health conditions that could prevent someone from joining, such as severe brain injury or specific bleeding disorders. Participants will receive either the study medication or a placebo (a harmless dummy treatment) and will be closely monitored throughout the trial. This research could be an important step toward better treatments for stroke patients in the future.

Gender

ALL

Eligibility 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