Status:
COMPLETED
Comparison Between Different Types of Oxygen Treatment Following Traumatic Brain Injury
Lead Sponsor:
Hennepin Healthcare Research Institute
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
16-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to study the effects of EARLY (no more than 24 four hours from injury) administration of extra amounts of oxygen on traumatic brain injury.
Detailed Description
Brain injury continues to be a major cause of death and disability throughout the world. Our investigations of hyperbaric oxygen treatment (HBOT) indicate that it is a relatively safe treatment that h...
Eligibility Criteria
Inclusion
- All closed head trauma victims with GCS score \< 8, when no effects from paralytics, sedation, alcohol and/or street drugs are present.
- Informed consent obtained.
- Entry into the study within 24 hours after injury.
- If a patient enters the hospital with a mild or moderate brain injury and subsequently deteriorates to a GCS \< 8 within 48 hours of admission, the patient is considered a candidate for entry into the study.
- CT scan score \> II in accordance with the classification system of the Traumatic Coma Data Bank.
Exclusion
- Consent could not be obtained.
- Patients who are brain dead or close to brain death (fixed, dilated pupils).
- Unstable pulmonary status requiring FiO2 of 50% or greater to maintain a PaO2 of 70 mm Hg or greater.
- History of severe pulmonary disease, such as COPD or asthma.
- Unstable fracture (spine, pelvis, femur, etc) preventing placement into the HBO chamber.
- Patients placed in barbiturate coma during initial management due to the potential effect barbiturates have on cerebral metabolism.
- Age range \< 16 years or \> 65 years.
- Coagulopathy.
- Pregnancy.
- Severe mental retardation or prior severe head injury.
- High velocity penetrating injury to the head,(e.g. gunshot wound).
- Multiple organ failure.
- Massive cerebral hemisphere or brainstem hematoma, stroke
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00170352
Start Date
November 1 2002
End Date
November 1 2008
Last Update
August 28 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415