Traumatic Brain InjuryPhase 2NCT00174980
Study of Oxycyte in Severe Closed Head Injury
A Phase 2 study testing Oxycyte in people with Traumatic Brain Injury, run by Tenax Therapeutics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Oxycyte
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Apr 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- no motor response
- both pupils fixed and dilated
- no consent available
- allergy to egg proteins
- coagulopathy
- major liver injury
- major pulmonary injury
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298
About this study
Official title: An Open Label, Proof of Concept Study, to Evaluate the Safety and Biological Effects of Oxycyte™ Perfluorocarbon in Patients With A Severe Head Injury Requiring Intracranial Pressure Monitoring-OX-CL-II-002
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.
Read the 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 improves functional outcome, and Oxycyte has been shown to be an effective means of delivering oxygen to tissues, including the brain. This study is an eight patient proof of concept study to test the effects of oxygen delivery with Oxycyte in patients with a severe traumatic head injury with a Glasgow Coma Scale (GCS) score of 3 to 9.
Subjects diagnosed with a severe head injury (GCS 3-9) who receive a brain oxygen monitor and microdialysis catheter, will undergo baseline monitoring for 4 hours. In the first 4 subjects the Fi02 on the ventilator will be increased to 50% for a 4 hour stabilization period and this will be followed by a single intravenous infusion of 3ml/kg of Oxycyte. The Fi02 will remain at 50% for 24 hours.
In the second 4 subjects the Fi02 on the ventilator will be increased to 100% for a 4 hour stabilization period and this will be followed by a single intravenous infusion of 3ml/kg of Oxycyte. The Fi02 will remain at 100% for 24 hours.
Subjects will be enrolled, treated, and then monitored by LICOX 02 monitor before and after infusion of PFC, and then for at least 48 hours following the discontinuation of Oxycyte.
- Conditions
- Traumatic Brain Injury
- Being tested
- Oxycyte
- Keywords
- Oxycyte, perfluorocarbon oxygen carrier, brain oxygen tension
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxycyteDrug
Also called perfluorocarbon
intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Oxycyte, perfluorocarbon | Experimental | one time dose of 3mL/kg over 15 minutes Receives: Drug: Oxycyte |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain Dialysate Concentration Data
Measured: 40 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionMar 2008
- Study completionApr 2008
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tenax Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- M. R Bullock, M.D., Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00174980
- Sponsor's protocol ID
- OX-CL-II-002
- Status last verified
- Oct 2012
- First submitted
- 9 Sep 2005
- Last updated
- 24 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Proof of Concept Study, to Evaluate the Safety and Biological Effects of Oxycyte™ Perfluorocarbon in Patients With A Severe Head Injury Requiring Intracranial Pressure Monitoring-OX-CL-II-002
- ClinicalTrials.gov ID
- NCT00174980
- Acronym / sponsor ID
- OX-CL-II-002
- Conditions
- Traumatic Brain Injury
- Keywords
- Oxycyte, perfluorocarbon oxygen carrier, brain oxygen tension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Tenax Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Mar 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Posted 24 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 improves functional outcome, and Oxycyte has been shown to be an effective means of delivering oxygen to tissues, including the brain. This study is an eight patient proof of concept study to test the effects of oxygen delivery with Oxycyte in patients with a severe traumatic head injury with a Glasgow Coma Scale (GCS) score of 3 to 9.
Subjects diagnosed with a severe head injury (GCS 3-9) who receive a brain oxygen monitor and microdialysis catheter, will undergo baseline monitoring for 4 hours. In the first 4 subjects the Fi02 on the ventilator will be increased to 50% for a 4 hour stabilization period and this will be followed by a single intravenous infusion of 3ml/kg of Oxycyte. The Fi02 will remain at 50% for 24 hours.
In the second 4 subjects the Fi02 on the ventilator will be increased to 100% for a 4 hour stabilization period and this will be followed by a single intravenous infusion of 3ml/kg of Oxycyte. The Fi02 will remain at 100% for 24 hours.
Subjects will be enrolled, treated, and then monitored by LICOX 02 monitor before and after infusion of PFC, and then for at least 48 hours following the discontinuation of Oxycyte.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oxycyte, perfluorocarbon | Experimental | Drug: Oxycyteone time dose of 3mL/kg over 15 minutes |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- no motor response
- both pupils fixed and dilated
- no consent available
- allergy to egg proteins
- coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxycyteAlso: perfluorocarbonintravenous infusion | Drug | Oxycyte, perfluorocarbon |
Primary outcome
Brain Dialysate Concentration Data
Time frame: 40 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M. R Bullock, M.D. principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxycyte in people with Traumatic Brain Injury, run by Tenax Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain Dialysate Concentration Data (time frame: 40 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.