This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the safety and preliminary efficacy of activated recombinant human factor VII (NovoSeven®) for preventing early hematoma growth in acute Intracerebral Hemorrhage (ICH).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
Subjects will be randomised to receive a single intravenous dose of either 5, 20, 40 and 80 mcg/kg body weight. Administered within the first 4 hours after the insult
Subjects will be randomised to receive a single intravenous dose. Administered within the first 4 hours after the insult
Novo Nordisk Investigational Site
New York, New York, United States
Occurrence of a treatment-related serious adverse event (SAE)
Occurrence of adverse events
Change in ICH volume as measured by CT head scans
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