'SPOT Sign' seLection of Intracerebral haemorrhage to Guide Haemostatic therapy

INTERVENTION: Patients randomised (1:1) to receive either a single intravenous bolus of 80 ug/kg rFVIIa (intervention group) NiaStase RT®, or placebo (control group). Treatment is administered one time. Total duration of follow up is 1 year, with follow‐up assessments post‐treatment and at 24 hours, days 1, 2, 3, 4, hospital discharge, day 30, day 90 and 1 year. CONDITION: Intracerebral hemorrhage (ICH) ; Circulatory System ; Intracerebral hemorrhage PRIMARY OUTCOME: ICH growth within 24 hours between the active drug and placebo. The ICH volume will be measured by analysing the baseline CT scan compared to the CT scan at 24 hours, by means of linear regression. The 24‐hour ICH volume will be summarised for each group by descriptive statistics and the adjusted treatment effect and 95% confidence interval will be obtained from the regression model. SECONDARY OUTCOME: Measured by completing CRF forms to capture date and time of study‐related assessments such as:; 1. Blood work; 2. Informed consent processes; 3. Vitals; 4. Well‐established grading scales, occurring at regular intervals. The grading scales are already used clinically by many sites, and are all incorporated into this trial. Patients will be assessed at baseline, immediately after dosing, days 1 ‐ 4, 30, 90 and 1 year post based on the following scales: ; 4.1. Glasgow Coma Scale; 4.2. NIH Stroke Scale; 4.3. Barthel Index; 4.4. Modified Rankin Score; 4.5. MoCA cognitive assessment; 4.6. Stroke Impact Scale; 4.7. EQ‐5D INCLUSION CRITERIA: Current inclusion criteria as of 24/04/2014: 1. Acute spontaneous primary supratentorial ICH diagnosed by CT scan 2. Presence of a spot sign within the hematoma on CTA (single‐phase, multi‐phase, or dynamic CTA). [Note: CTA should ideally be performed immediately after the baseline CT scan. If CTA is going to be delayed more than 20 minutes after the baseline CT, then a new plain head CT must be obtained immediately prior to CTA which will serve as the baseline CT for the study]. A spot sign must meet the following criteria: 2.1. One or more foci of contrast enhancement within the margin of a parenchymal hematoma 2.2. Any size or morphology (shape may be spot‐like, linear or serpiginous) 2.3. Spot sign(s) must not have any connection to vessels outside the hematoma 2.4. Hounsfield unit density greater than background hematoma density (density of spot sign is typically >120 Hounsfield units) 2.5. No corresponding density present within the hemato