Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial - Part 2

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 strokeonset or last known well with a positive spot sign on pretreatment CT angiography ortreatment within 90 minutes with or without spot sign.

4. Efforts to obtain informed consent per EFIC guidelines (U.S.) or adherence tocountry-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, arteriovenousmalformation (AVM), oral anticoagulant use (vitamin K antagonists or novel oralanticoagulants) 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 fillingat 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., cerebralinfarction, myocardial infarction, pulmonary embolus, deep vein thrombosis, orunstable angina)

7. Clinical or EKG evidence of ST elevation consistent with acute myocardial ischemia

8. Brainstem location of hemorrhage (patients with cerebellar hemorrhage may beenrolled)

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 FASTESTtrial (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 cerebrovascularangioplasty or stenting

15. Advanced or terminal illness or any other condition the investigator feels wouldpose a significant hazard to the patient if rFVIIa were administered

16. Recent (within 30 days) participation in any investigational drug or device trial orearlier participation in any investigational drug or device trial for which theduration 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 weekspost-partum and/or lactating at time of enrollment -