Acquired Bleeding Disorder, Intracerebral Haemorrhage
Conditions
Brief summary
This trial is conducted in Asia, Europe, Middle East, North America, Oceania, and South America. The purpose of this study is to evaluate the treatment of Recombinant Factor VIIa (eptacog alfa (activated)) in patients with acute intracerebral bleeding. It is expected that more patients will recover without severe permanent disability after acute treatment with Recombinant Factor VIIa by reducing further intracerebral bleeding.
Interventions
DRUGeptacog alfa (activated)
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Spontaneous intracranial hemorrhage (ICH) within 3 hours after first symptom
Exclusion criteria
* Patients with secondary ICH * Pre-existing disability * Haemophilia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reducing disability and improving clinical outcome | After 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Reducing mortality | — |
| Reducing hematoma growth | — |
Countries
Australia, Austria, Belgium, Brazil, Canada, China, Croatia, Denmark, Finland, France, Germany, Hong Kong, Israel, Italy, Netherlands, Norway, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, United States
Outcome results
None listed