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Comparison Between Different Types of Oxygen Treatment Following Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00170352
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : August 28, 2015
Information provided by:
Hennepin Healthcare Research Institute.

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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Procedure: Hyperbaric Oxygen Treatment (HBOT) Procedure: Enhanced Oxygen Treatment (Enhanced FiO2) Phase 2

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 has promise as a potential therapy for patients with severe traumatic brain injury (TBI). The goals of the present proposal are to further elucidate the mechanisms of action of HBOT on severe TBI and to test hypotheses that are crucial to the possible future design of a Phase III clinical trial.

Our initial prospective clinical trial to assess the effectiveness of HBOT in severe TBI documented very significant improvement in survival, particularly in certain subgroups of patients. In our second study, HBOT was found to improve cerebral aerobic metabolism in patients with severe TBI, reduce elevated intracranial pressure, and had a persistent positive effect for at least six hours following the treatment. Our work suggests that HBOT allows the brain to utilize increased amounts of oxygen more efficiently following treatment.

Recently, increasing the inspired oxygen concentration (FiO2) to 100% has been proposed as an alternative way of delivering supranormal levels of oxygen to severe TBI patients. Experimental investigation in the fluid percussion rat model using HBOT at 1.5 ATA (atmospheres absolute) for 60 minutes followed by 3 hours of 100%fraction of inspired oxygen (FiO2) have given optimum results in terms of mitochondrial functional and neurobehavioral improvement.

The clinical and experimental data together provide a strong basis for the restorative effect of the combination of hyper- and normobaric hyperoxia on severe TBI. The goal of this study is to evaluate the use of HBOT and 100% FiO2 separately and in combination.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hyperbaric and Normobaric Oxygen in Severe Brain Injury
Study Start Date : November 2002
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Cerebral Metabolic Rate of Oxygen (CMRO2)
  2. Microdialysis Lactate
  3. Brain tissue oxygen (PtO2)
  4. Intracranial Pressure (ICP)

Secondary Outcome Measures :
  1. Microdialysis-Glycerol,Glucose,Pyruvate,Lactate/Pyruvate Ratio
  2. Cerebral Spinal Fluid (CSF) Lactate
  3. Arterial-Venous Oxygen Difference (AVDO2)
  4. Cerebral Blood Flow (CBF)
  5. Cerebral Spinal Fluid Isoprostane
  6. Bronchial-Alveolar Lavage Cytokines

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00170352

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United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Sponsors and Collaborators
Hennepin Healthcare Research Institute.
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Principal Investigator: Gaylan L Rockswold, M.D., PhD Hennepin County Medical Center, Minneapolis
Study Director: Sarah B Rockswold, M.D. Hennepin County Medical Center, Minneapolis

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00170352     History of Changes
Other Study ID Numbers: HSR2000-858
NIH-5 RO1 NS042126-03
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: August 28, 2015
Last Verified: August 2015

Keywords provided by Hennepin Healthcare Research Institute.:
hyperbaric oxygen
cerebral metabolism
traumatic brain injury

Additional relevant MeSH terms:
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Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System