Study of Oxycyte in Severe Closed Head Injury
|Traumatic Brain Injury||Drug: perfluorocarbon emulsion (Oxycyte) infusion||Phase 2|
|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|
- Increase in Brain Oxygen Tension levels in severe traumatic head injury patients with GCS score of 3-9
- 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
|Study Start Date:||September 2005|
|Study Completion Date:||July 2008|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
Drug: perfluorocarbon emulsion (Oxycyte) infusion
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00174980
|United States, Virginia|
|Virginia Commonwealth University Medical Center|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||M. R Bullock, M.D.||Virginia Commonwealth University|