Comparison Between Different Types of Oxygen Treatment Following Traumatic Brain Injury

NCT ID: NCT00170352

Last Updated: 2015-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-11-30
• Study Completion Date: 2008-11-30

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 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.

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Hyperbaric Oxygen Treatment (HBOT)

Intervention Type: PROCEDURE

Enhanced Oxygen Treatment (Enhanced FiO2)

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hennepin Healthcare Research Institute

OTHER

Sponsor Role: lead

Principal Investigators

Gaylan L Rockswold, M.D., PhD

Role: PRINCIPAL_INVESTIGATOR

Hennepin County Medical Center, Minneapolis

Sarah B Rockswold, M.D.

Role: STUDY_DIRECTOR

Hennepin County Medical Center, Minneapolis

Locations

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 23510092 (View on PubMed)

Other Identifiers

NIH-5 RO1 NS042126-03

Identifier Type: -

Identifier Source: secondary_id

HSR2000-858

Identifier Type: -

Identifier Source: org_study_id