Trial | NCT00174980  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    perfluorocarbon ...

  • Study Participants

    9
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.
Study Started
Sep 30
2005
Primary Completion
Jan 31
2008
Study Completion
Jul 31
2008
Last Update
Jun 10
2011
Estimate

Drug perfluorocarbon emulsion (Oxycyte) infusion

one time dose of 3mL/kg over 15 minutes

  • Other names: Oxycyte

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
No Results Posted