Study of Oxycyte in Severe Closed Head Injury

NCT ID: NCT00174980

Last Updated: 2011-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2008-07-31

Brief Summary

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.

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.

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

perfluorocarbon emulsion (Oxycyte) infusion

one time dose of 3mL/kg over 15 minutes

Intervention Type: DRUG

Other Intervention Names

Oxycyte

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: collaborator

Tenax Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Oxygen Biotherapeutics, Inc

Principal Investigators

M. R Bullock, M.D.

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University Medical Center

Richmond, Virginia, United States

Countries

United States

Other Identifiers

OX-CL-II-002

Identifier Type: -

Identifier Source: org_study_id