Study of Oxycyte in Severe Closed Head Injury

This study has been completed.
Sponsor:
Collaborator:
Virginia Commonwealth University
Information provided by:
Oxygen Biotherapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00174980
First received: September 9, 2005
Last updated: June 9, 2011
Last verified: October 2008

September 9, 2005
June 9, 2011
September 2005
January 2008   (final data collection date for primary outcome measure)
Increase in Brain Oxygen Tension levels in severe traumatic head injury patients with GCS score of 3-9
Same as current
Complete list of historical versions of study NCT00174980 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Study of Oxycyte in Severe Closed Head Injury
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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Traumatic Brain Injury
Drug: perfluorocarbon emulsion (Oxycyte) infusion
one time dose of 3mL/kg over 15 minutes
Other Name: Oxycyte
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
July 2008
January 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00174980
OX-CL-II-002
Not Provided
Timothy Bradshaw, SVP Clinical Development, Oxygen Biotherapeutics, Inc
Oxygen Biotherapeutics, Inc.
Virginia Commonwealth University
Principal Investigator: M. R Bullock, M.D. Virginia Commonwealth University
Oxygen Biotherapeutics, Inc.
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP