Hyperbaric Oxygen Brain Injury Treatment Trial

Summary

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

Interventions

DRUG

Hyperbaric oxygen (1.5 ATA, no NBH)

HBO at 1.5 ATA for 60 minutes without NBH. Treatment will be twice a day for five days or until patient is following commands or brain dead

DRUG

Hyperbaric oxygen (2.0 ATA, no NBH)

HBO at 2.0 ATA for 60 minutes without NBH. Treatment will be twice a day for five days or until patient is following commands or brain dead

DRUG

Hyperbaric oxygen (2.5 ATA, no NBH)

HBO at 2.5 ATA for 60 minutes without NBH. Treatment will be twice a day for five days or until patient is following commands or brain dead

DRUG

Hyperbaric oxygen (1.5 ATA + NBH)

HBO at 1.5 ATA for 60 minutes followed by NBH for 3 hours. Treatment will be twice a day for five days or until patient is following commands or brain dead

DRUG

Hyperbaric oxygen (2.0 ATA + NBH)

HBO at 2.0 ATA for 60 minutes followed by NBH for 3 hours. Treatment will be twice a day for five days or until patient is following commands or brain dead

DRUG

Hyperbaric oxygen (2.5 ATA + NBH)

HBO at 2.5 ATA for 60 minutes followed by NBH for 3 hours. Treatment will be twice a day for five days or until patient is following commands or brain dead

DRUG

Normobaric Hyperoxia (NBH)

100% fraction of inspired oxygen (FiO2) for 4.5 hours twice a day for five days or until patient following commands or brain dead

OTHER

Usual Care

Will be treated with usual and customary care for severe traumatic brain injury

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS)

  collaborator NIH

• Strategies to Innovate EmeRgENcy Care Clinical Trials Network

  collaborator NETWORK

• Gaylan Rockswold

  lead OTHER

Principal Investigators

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

• William Barsan, MD · University of Michigan

• Byron Gajewski, Ph.D. · University of Kansas Medical Center

• Frederick K Korley, M.D., Ph.D. · University of Michigan

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

16 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-06-25

Primary Completion

2028-10-26

Completion

2029-06-30

FDA Drug

Yes

Countries

• United States
• Canada

Study Locations