TerminatedPhase 2

Study of Oxycyte in Severe Closed Head Injury

Stopped: Low enrollment

United States9 participantsStarted 2005-09

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Brain Dialysate Concentration Data

Timeframe: 40 hours

Trial details

NCT IDNCT00174980

SponsorTenax Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-03

Results submitted2016-10-17

View on ClinicalTrials.gov More Traumatic Brain Injury trials