HOBIT (Traumatic Brain Injury)

Purpose of this Study

We are doing this study to learn if hyperbaric oxygen therapy is helpful to people with traumatic brain injury.

Who Can Participate?

Eligibility

Children and adults ages 16-65 who:
<li>Have a traumatic brain injury</li>
<li>Able to complete their first hyperbaric treatment within 8-14 hours of being admitted to the hospital</li></ul>

Age Range

16-65

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

If you choose to join this, study you will get a random assignment (like drawing numbers out of a hat) to be 1 one of 8 groups:
<li>6 groups will receive hyperbaric oxygen therapy</li>
<li>1 group will receive a high dose of oxygen that is not pressurized</li>
<li>1 group will get standard care</li></ul>
All study participants will complete a follow-up visit (on the phone or in-person) at months 3 and 6 after treatment.

Locations

Duke University Hospital

Visit Timing

Weekdays
Weekends
Evenings

Compensation

No

Spanish Materials Available

No

Study Details

Full Title

Hyperbaric Oxygen Brain Injury Treatment (HOBIT) Trial: A Multicenter, Randomized, Prospective Phase II Adaptive Clinical Trial Evaluating the Most Effective Hyperbaric Oxygen Treatment Paradigm for Severe Traumatic Brain Injury

Principal Investigator

Katharine
Colton

Protocol Number

PRO00093798

NCT ID

NCT02407028

Phase

II

Enrollment Status

Open to Enrollment