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Study of Oxycyte in Severe Closed Head Injury

StatusTerminated
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Completed to Terminated Results first posted: Feb 24, 2026 · Primary endpoint revised · Sponsor's reason: Low enrollment · 6 morev6 Show 9 more changesShow less
    • Results first posted: Feb 24, 2026
    • Primary endpoint revised
    • Sponsor's reason: Low enrollment
    • Primary completion date: Jan 2008 to Mar 2008
    • Completion date: Jul 2008 to Apr 2008
    • Interventions: perfluorocarbon emulsion (Oxycyte) infusion (Drug) to Oxycyte (Drug)
    • Secondary endpoints shortened, about 29 words
    • Study arms: 0 to 1
    • Collaborators shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  2. Interventions: Oxycyte infusion (Drug) to perfluorocarbon emulsion (Oxycyte) infusion (Drug) Study title shortened, about 3 wordsv5 Show 1 more changeShow less
    • Study title shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study title expanded, about 2 wordsv4 See this version in full on ClinicalTrials.gov ↗
  4. Trial status: Recruiting to Completed Enrollment target: 8 to 9 · Primary completion date: Jan 2008 · Completion date: Oct 2006 to Jul 2008 · 1 morev3 Show 4 more changesShow less
    • Enrollment target: 8 to 9
    • Primary completion date: Jan 2008
    • Completion date: Oct 2006 to Jul 2008
    • Site details revised
  5. Re-verified, no change to tracked fieldsv2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00174980
Lead Sponsor Tenax Therapeutics, Inc.
Conditions Traumatic Brain Injury
Enrollment 9 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov