Study of Oxycyte in Severe Closed Head Injury

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

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 oxygen in the brain results in better brain oxygen consumption, less cell death, and better functional outcome. This study will test the hypothesis that Oxycyte is an effective way to increase brain oxygen levels in severe head injury.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tenax Therapeutics, Inc.
• Collaborator: Virginia Commonwealth University

Criteria

Inclusion Criteria:

• 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 Criteria:

• no motor response

• both pupils fixed and dilated

• no consent available

• allergy to egg proteins

• coagulopathy

• major liver injury

• major pulmonary injury