Intercranial Hemorrhage – FASTEST

Study name:  rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST)

PI: Anna Khanna, MD

Study Coordinator: Amy Holland, BSN, RN 

SC email: amy.holland@neurology.ufl.edu

SC phone: 806-790-3877

Enrolling hours: 24/7

Diagnosis: Hemorrhagic stroke

Objective: To test the hypothesis that treatment with rFVIIa within 2 hours of onset in appropriately selected patients with spontaneous ICH and a positive spot sign on CTA or treated within 90 minutes with or without a positive spot sign, improves outcome as measured by the modified Rankin Scale (mRS) at 90 days, as compared to placebo.

Inclusion Criteria:

1. Acute spontaneous ICH
2. Age 18-80
3. GCS > 7
4. Not on anticoagulant
5. Pre-stroke mRS 0-2
6. Able to be treated with study med within 2 hours of onset or LKW
7. Positive spot sign on CTA or treat within 90 min with or without a positive spot sign
8. ICH volume of ≥ 2 cc and < 60 cc *
9. Efforts to obtain informed consent per EFIC guidelines

Exclusion Criteria:

1. 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.)
2. Blood filling 2/3 or more of one lateral ventricle of the brain, OR blood filling at least 1/3 of both lateral ventricles
3. Symptomatic thrombo-embolic or vaso-occlusive disease in past 90 days (e.g., cerebral infarction, myocardial infarction, PE, DVT, or unstable angina)
4. Clinical or EKG evidence of ST elevation consistent with acute MI
5. Brainstem location of hemorrhage (patients with cerebellar hemorrhage may be enrolled)
6. Known or suspected thrombocytopenia (unless current platelet count documented >50K)
7. Unfractionated heparin use with abnormal PTT
8. Low-molecular weight heparin use within the previous 24 hours
9. Recent (90 days) carotid endarterectomy or coronary or cerebrovascular angioplasty or stenting
10. Advanced or terminal illness or any other condition the investigator feels would pose a significant hazard to the patient if rFVIIa were administered
11. 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 the time of FASTEST +enrollment
12. Planned [or high probability of] withdrawal of care or comfort care measures
13. Patient known or suspected of not being able to comply with trial protocol (e.g., due to alcoholism, drug dependency, homelessness, or psychological disorder)
14. Known suspected allergy or contraindication to trial medication
15. Previous participation in this trial (previously randomized)
16. Females of childbearing potential who are known to be pregnant or within 12 weeks post-partum and/or lactating at time of enrollment