RECRUITING

Hyperbaric Oxygen Brain Injury Treatment Trial

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Hyperbaric Oxygen Brain Injury Treatment (HOBIT) Trial

Quick Facts

Study Start:2018-06-25

Study Completion:2027-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02407028

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.

Ages Eligible for Study:16 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Gaylan L. Rockswold, M.D., Ph.D.

CONTACT

612-873-2810

gaylan.rockswold@hcmed.org

Principal Investigator

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 Locations (Sites)

UCSD Medical Center - Hillcrest Hospital

San Diego, California, 92103

United States

St. Mary's Medical Center

West Palm Beach, Florida, 33407

United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242

United States

University of Kentucky Hospital

Lexington, Kentucky, 40536

United States

University of Maryland

Baltimore, Maryland, 21201

United States

Detroit Receiving Hospital

Detroit, Michigan, 48201

United States

Hennepin County Hospital

Minneapolis, Minnesota, 55415

United States

University of Nebraska Medical Center

Omaha, Nebraska, 68198

United States

Duke University Hospital

Durham, North Carolina, 27710

United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210

United States

Collaborators and Investigators

Sponsor: 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

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 Registration Dates

Study Start Date2018-06-25

Study Completion Date2027-06

Study Record Updates

Study Start Date2018-06-25

Study Completion Date2027-06

Terms related to this study

Additional Relevant MeSH Terms

Traumatic Brain Injury