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 range

18 Years – 70 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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