Status:
COMPLETED
Safety and Preliminary Efficacy of Recombinant Activated Factor VII in Subjects With Traumatic Brain Injury
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Acquired Bleeding Disorder
Trauma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This trial is conducted in Asia, Europe, Middle East, and North America. The primary objective of the trial is to evaluate the safety of Recombinant Activated Factor VII in patients with brain contusi...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Contusive brain injury (including brain stem) diagnosed by history, clinical examination and confirmed by CT scan within 6 hours of onset
- In British Columbia and Nova Scotia, subjects must be = 19 years.
Exclusion
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2006
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00123591
Start Date
January 1 2005
End Date
May 1 2006
Last Update
January 12 2017
Active Locations (15)
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1
Novo Nordisk Investigational Site
Montreal, Canada, H3G 1A4
2
Novo Nordisk Investigational Site
Helsinki, Finland, 00250
3
Novo Nordisk Investigational Site
Hanover, Germany, 30625
4
Novo Nordisk Investigational Site
New Dehli, New Delhi, India, 110029