Comparison Between Different Types of Oxygen Treatment Following Traumatic Brain Injury
Completed · Phase 2
Conditions studied: Traumatic Brain Injury
In brief
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.
Key facts
- Study ID
- NCT00170352
- Run by
- Hennepin Healthcare Research Institute
- People needed
- 80
- Starts
- 2002-11-01
- Expected to finish
- 2008-11-01
- Last updated by the study team
- 2015-08-28
Who can join
Age: 16 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Hennepin County Medical Center — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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