Comparison Between Different Types of Oxygen Treatment Following Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

Official title:

Hyperbaric and Normobaric Oxygen in Severe Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00170352
• Other study ID #: HSR2000-858
• Secondary ID: NIH-5 RO1 NS0421
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: August 27, 2015
• Start date: November 2002
• Est. completion date: November 2008

Study information

• Verified date: August 2015
• Source: Minneapolis Medical Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2008
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury

Intervention

Procedure:
• Hyperbaric Oxygen Treatment (HBOT)

• Enhanced Oxygen Treatment (Enhanced FiO2)

Locations

Country	Name	City	State
United States	Hennepin County Medical Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Minneapolis Medical Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral Metabolic Rate of Oxygen (CMRO2)
Primary	Microdialysis Lactate
Primary	Brain tissue oxygen (PtO2)
Primary	Intracranial Pressure (ICP)
Secondary	Microdialysis-Glycerol,Glucose,Pyruvate,Lactate/Pyruvate Ratio
Secondary	Cerebral Spinal Fluid (CSF) Lactate
Secondary	Arterial-Venous Oxygen Difference (AVDO2)
Secondary	Cerebral Blood Flow (CBF)
Secondary	Cerebral Spinal Fluid Isoprostane
Secondary	Bronchial-Alveolar Lavage Cytokines