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Subjects: 399 adults age 18 years or older with spontaneous intracerebral hemorrhage documented by CT scanning within 3 hours of onset of symptoms. Exclusion criteria included a score of 3 to 5 on the Glasgow Coma Scale (indicating deep coma); planned surgical evacuation of hematoma within 24 hours after admission; secondary intracerebral hemorrhage related to aneurysm, arteriovenous malformation, trauma, or other causes; known use of oral anticoagulant agents; known thrombocytopenia; history of coagulopathy, acute sepsis, crush injury, or disseminated intravascular coagulation; pregnancy; preexisting disability; and symptomatic thrombotic or vasoocclusive disease within 30 days before the onset of symptoms of intracerebral hemorrhage. Midway through the trial, the last criterion was amended to exclude patients with any history of thrombotic or vaso-occlusive disease.

Early recombinant activated factor VII for intracerebral hemorrhage reduced hematoma growth and mortality, while improving functional outcomes.