Comparison Between Different Types of Oxygen Treatment Following Traumatic Brain Injury

This study has been completed.
Sponsor:
Information provided by:
Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier:
NCT00170352
First received: September 12, 2005
Last updated: October 3, 2012
Last verified: December 2008
  Purpose

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 Intervention Phase
Traumatic Brain Injury
Procedure: Hyperbaric Oxygen Treatment (HBOT)
Procedure: Enhanced Oxygen Treatment (Enhanced FiO2)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hyperbaric and Normobaric Oxygen in Severe Brain Injury

Resource links provided by NLM:


Further study details as provided by Minneapolis Medical Research Foundation:

Primary Outcome Measures:
  • Cerebral Metabolic Rate of Oxygen (CMRO2)
  • Microdialysis Lactate
  • Brain tissue oxygen (PtO2)
  • Intracranial Pressure (ICP)

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

Enrollment: 80
Study Start Date: November 2002
Study Completion Date: November 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00170352

Locations
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Sponsors and Collaborators
Minneapolis Medical Research Foundation
Investigators
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
  More Information

No publications provided by Minneapolis Medical Research Foundation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00170352     History of Changes
Other Study ID Numbers: HSR2000-858, NIH-5 RO1 NS042126-03
Study First Received: September 12, 2005
Last Updated: October 3, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Minneapolis Medical Research Foundation:
hyperbaric oxygen
cerebral metabolism
hyperoxia
traumatic brain injury

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

ClinicalTrials.gov processed this record on August 28, 2014