Hyperbaric Oxygen Treatment (HBOT) and Enhanced Oxygen Treatment (Enhanced FiO2) in Traumatic Brain Injury - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Traumatic Brain Injury

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Minnesota
  - Minneapolis, Minnesota, United States, 55415
    - Hennepin County Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Factorial Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Cerebral Metabolic Rate of Oxygen (CMRO2)
Microdialysis Lactate
Brain tissue oxygen (PtO2)
Intracranial Pressure (ICP)

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hennepin Healthcare Research Institute

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Rockswold SB, Rockswold GL, Zaun DA, Liu J. A prospective, randomized Phase II clinical trial to evaluate the effect of combined hyperbaric and normobaric hyperoxia on cerebral metabolism, intracranial pressure, oxygen toxicity, and clinical outcome in severe traumatic brain injury. J Neurosurg. 2013 Jun;118(6):1317-28. doi: 10.3171/2013.2.JNS121468. Epub 2013 Mar 19.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria