"Spot Sign" Selection of Intracerebral Hemorrhage to Guide Hemostatic Therapy (SPOTLIGHT)

Inclusion Criteria

• Acute spontaneous primary supratentorial ICH diagnosed by CT scan.
• Presence of a spot sign within the hematoma on CTA source images
• Baseline ICH volume 3-70 ml
• Age 18-85 years
• Investigator is able to randomize and administer study drug within 60 minutes after CT angiogram and no later than 6 hours after stroke symptom onset (using the "last seen normal" principle).
• Assent-consent from patient or LAR prior to enrolment, or a waiver of consent if patient/LAR assent-consent is not possible prior to enrolment.

Exclusion Criteria

• Brainstem or cerebellar hemorrhage.
• ICH secondary to known or suspected trauma, aneurysm, vascular malformation, hemorrhagic conversion of ischemic stroke, venous sinus thrombosis, thrombolytic treatment, tumour, or infection; or an in-hospital ICH or ICH as a result of any in-hospital procedure or illness.
• Baseline brain imaging shows evidence of acute or subacute ischemic stroke (chronic infarcts are not an exclusion).
• Contrast administration within the previous 24 hours.
• Glasgow Coma Scale score <8, at time of initial screening by the enrolling investigator/nurse.
• Known pre-existing dependence or moderate or severe disability, defined as pre-admission modified Rankin Scale score >2
• Evidence of thromboembolic risk factors, defined as any of the following: known history within the past 6 months of any of the following: (a) myocardial infarction, (b) coronary artery bypass surgery, (c) angina, (d) ischemic stroke, (e) transient ischemic attack, (f) carotid endarterectomy, (g) cerebral bypass surgery, (h) deep venous thrombosis, (i) pulmonary embolism, (j) any vascular angioplasty, stenting (coronary, peripheral vascular or cerebrovascular) or filter (e.g. vena cava filter); and/or known history of a high-risk thrombophilia (e.g. antithrombin III deficiency, antiphospholipid antibody syndrome, protein C deficiency, etc.)
• Known hereditary (e.g. hemophilia) or acquired hemorrhagic diathesis or coagulation factor deficiency.
• Any condition known that the investigator feels would pose a significant hazard if rFVIIa were administered.
• Planned surgery for ICH within 24 hours (placement of intraventricular catheter is not an exclusion).
• Known terminal illness or planned withdrawal of care or comfort care measures.
• Known participation in another therapeutic trial.
• Known allergy or other contraindication to iodinated contrast dye.
• Known or suspected hypersensitivity to the trial product.
• Known unfractionated heparin use - must check PTT and exclude if elevated above upper limit of local lab's reference range.
• Known low-molecular weight heparin, heparinoid, factor X inhibitor, or direct thrombin inhibitor use within previous 24 hours.
• Known GPIIb/IIIa antagonist use in previous 2 weeks.
• Known warfarin (or other anticoagulant) therapy with INR >1.40. Note: if the patient is suspected to have cirrhosis, study staff are to wait for the INR value prior to dosing, and ensure not to enroll the patient if the INR value is >1.40. Otherwise the physician should use their discretion if they believe the patient is not at risk for elevated INR.
• Concurrent or planned treatment with prothrombin complex concentrate, vitamin K, fresh frozen plasma, or platelet transfusion.
• Pregnancy or lactation. Women of childbearing potential must have a negative pregnancy test prior to randomization.
• Current clinical symptoms suggestive of acute coronary ischemia (e.g. chest pain).
• Baseline ECG evidence of acute coronary ischemia (e.g. ST elevation in 2 contiguous leads, new LBBB, ST depression).
• Baseline troponin T or troponin I >0.1 ng/ml (>0.1 µg/L).
• Baseline platelet count <50,000 or INR >1.40 or elevated PTT