Study of Oxycyte in Severe Closed Head Injury

Stopped early · Phase 2

Conditions studied: Traumatic Brain Injury

In brief

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.

Key facts

Study ID

NCT00174980

Run by

Tenax Therapeutics, Inc.

People needed

9

Starts

2005-09-01

Expected to finish

2008-04-01

Last updated by the study team

2026-02-24

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• no motor response
• both pupils fixed and dilated
• no consent available
• allergy to egg proteins
• coagulopathy
• major liver injury
• major pulmonary injury

Where it is running

• Virginia Commonwealth University Medical Center — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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