Study of Oxycyte in Severe Closed Head Injury
| Status: | Completed |
|---|---|
| Conditions: | Hospital, Hospital, Neurology |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 10/14/2017 |
| Start Date: | September 2005 |
| End Date: | July 2008 |
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.
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.
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.
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
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Virginia Commonwealth University Medical Center The Virginia Commonwealth University Health System is an urban, comprehensive...
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