Hyperbaric Oxygen Brain Injury Treatment Trial

Description

The purpose of this innovative adaptive phase II trial design is to determine the optimal combination of hyperbaric oxygen treatment parameters that is most likely to demonstrate improvement in the outcome of severe TBI patients in a subsequent phase III trial.

Conditions

Traumatic Brain Injury

Talk to us

Study Overview

On this page

Study Details

Study overview

The purpose of this innovative adaptive phase II trial design is to determine the optimal combination of hyperbaric oxygen treatment parameters that is most likely to demonstrate improvement in the outcome of severe TBI patients in a subsequent phase III trial.

Hyperbaric Oxygen Brain Injury Treatment (HOBIT) Trial

Hyperbaric Oxygen Brain Injury Treatment Trial

Condition
Traumatic Brain Injury
Intervention / Treatment

-

Contacts and Locations

San Diego

UCSD Medical Center - Hillcrest Hospital, San Diego, California, United States, 92103

West Palm Beach

St. Mary's Medical Center, West Palm Beach, Florida, United States, 33407

Iowa City

University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States, 52242

Lexington

University of Kentucky Hospital, Lexington, Kentucky, United States, 40536

Baltimore

University of Maryland, Baltimore, Maryland, United States, 21201

Detroit

Detroit Receiving Hospital, Detroit, Michigan, United States, 48201

Minneapolis

Hennepin County Hospital, Minneapolis, Minnesota, United States, 55415

Omaha

University of Nebraska Medical Center, Omaha, Nebraska, United States, 68198

Durham

Duke University Hospital, Durham, North Carolina, United States, 27710

Columbus

The Ohio State University Wexner Medical Center, Columbus, Ohio, United States, 43210

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age 16 years or older and 65 years or younger
  • * Present with severe TBI, defined as Glasgow Coma Scale (GCS) of 3 to 8.
  • * Marshall computerized tomography (CT) score \>1 in patients with a GCS of 7 or 8 or patients with an alcohol level \>200 mg/dl
  • * Ability to initiate the first hyperbaric oxygen treatment within 8 hours of admission in patients not requiring a craniotomy/craniectomy or any other major surgical procedure OR
  • * Ability to initiate the first hyperbaric oxygen treatment within 14 hours of admission in patients requiring a craniotomy/craniectomy or major surgical procedure
  • * First hyperbaric oxygen treatment cannot be initiated within 24 hours of injury
  • * GCS of 3 with mid-position and non-reactive pupils bilaterally (4mm)
  • * Penetrating head injury
  • * Pregnant
  • * Pre-existing neurologic disease (e.g. TBI or stroke or neurodegenerative disorder) with confounding residual neurologic deficits
  • * Unstable acute spinal cord injury
  • * Fixed coagulopathy
  • * Severe hypoxia
  • * Cardiopulmonary resuscitation performed
  • * Coma suspected to de due to primarily non-TBI causes
  • * Any contraindications to the study intervention

Ages Eligible for Study

16 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Hennepin Healthcare Research Institute,

Gaylan L Rockswold, M.D., Ph.D., PRINCIPAL_INVESTIGATOR, Hennepin County Medical Center, Minneapolis

William Barsan, MD, PRINCIPAL_INVESTIGATOR, University of Michigan

Byron Gajewski, Ph.D., PRINCIPAL_INVESTIGATOR, University of Kansas Medical Center

Frederick K Korley, M.D., Ph.D., PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

2027-06