Patients may have extracerebral (e.g., subdural, subarachnoid, epidural) or extracranial (e.g., gastrointestinal, intraspinal) bleeding additionally, but the intracerebral hemorrhage must be considered the most clinically significant bleed at the time of enrollment. An acute intracerebral bleeding episode, defined as an estimated blood volume ≥ 0.5 to ≤ 60 mL acutely observed radiographically within the cerebrum.Age ≥ 18 years old at the time of consent.

In all cases where the patient does not sign informed consent prior to study entry, informed consent from the patient will be obtained as soon as realistically possible after inclusion in the trial and in accordance with the Declaration of Helsinki, International Conference on Harmonization-Good Clinical Practice (GCP), the Data Protection Directive (Directive 95/46/EC) and national and local regulations.In cases of deferred consent, the time of the study physician's documented decision to include the patient into the study will serve as 'time of consent' with respect to protocol-specific procedures. Deferred consent procedure is allowed where approved by local ethics committees.Either the patient or his or her medical proxy (or legally authorized representative if permissible by local or regional laws and regulations) has been adequately informed of the nature and risks of the study and has given written informed consent prior to Screening. Why Should I Register and Submit Results?.

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