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Study of Oxycyte in Severe Closed Head Injury

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00174980
First Posted: September 15, 2005
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Virginia Commonwealth University
Information provided by:
Tenax Therapeutics, Inc.
  Purpose
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.

Condition Intervention Phase
Traumatic Brain Injury Drug: perfluorocarbon emulsion (Oxycyte) infusion Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Tenax Therapeutics, Inc.:

Primary Outcome Measures:
  • Increase in Brain Oxygen Tension levels in severe traumatic head injury patients with GCS score of 3-9

Secondary Outcome Measures:
  • Adverse events will be captured throughout drug infusion and 2 weeks post, Severe adverse events will be captured for 6 months. Glascow outcomes score at 3 and 6 months

Enrollment: 9
Study Start Date: September 2005
Study Completion Date: July 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: perfluorocarbon emulsion (Oxycyte) infusion
    one time dose of 3mL/kg over 15 minutes
    Other Name: Oxycyte
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00174980


Locations
United States, Virginia
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Tenax Therapeutics, Inc.
Virginia Commonwealth University
Investigators
Principal Investigator: M. R Bullock, M.D. Virginia Commonwealth University
  More Information

Responsible Party: Timothy Bradshaw, SVP Clinical Development, Oxygen Biotherapeutics, Inc
ClinicalTrials.gov Identifier: NCT00174980     History of Changes
Other Study ID Numbers: OX-CL-II-002
First Submitted: September 9, 2005
First Posted: September 15, 2005
Last Update Posted: October 12, 2017
Last Verified: October 2008

Keywords provided by Tenax Therapeutics, Inc.:
Oxycyte
perfluorocarbon oxygen carrier
brain oxygen tension

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Craniocerebral Trauma
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System