Status:
COMPLETED
Study of Oxycyte in Severe Closed Head Injury
Lead Sponsor:
Tenax Therapeutics, Inc.
Collaborating Sponsors:
Virginia Commonwealth University
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Brain damage as a result of decreased oxygen to the brain is found in 80% of patients that die with severe head injuries. Laboratory studies in animals and clinical trials have shown that increasing o...
Detailed Description
Decreased brain oxygen in severe brain injuries appears to be implicated in poor functional outcome and death. Animal and clinical studies have shown that increasing brain oxygen in such patients impr...
Eligibility Criteria
Inclusion
- severe closed head injury patients or GCS 3-9 patients who receive brain oxygen monitoring
- ventriculostomy/ICP monitor
- at least one reactive pupil
- no known life threatening disease prior to trauma
- age 18-70 years old
- consent for microdialysis/brain 02 monitoring
- legal family representative present that can give informed consent for perfluorocarbon administration
Exclusion
- no motor response
- both pupils fixed and dilated
- no consent available
- allergy to egg proteins
- coagulopathy
- major liver injury
- major pulmonary injury
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00174980
Start Date
September 1 2005
End Date
July 1 2008
Last Update
June 10 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States, 23298