HOBIT (Traumatic Brain Injury) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn if hyperbaric oxygen therapy (HBOT) is helpful to people with traumatic brain injury.
What is the Condition Being Studied?
Traumatic Brain Injury (TBI)

Who Can Participate in the Study?

- Men and Women 16-65 years old
- Have a traumatic brain injury
- Able to complete their first hyperbaric treatment within 8-14 hours of being admitted to the hospital

Age Group
Adults, Children

What is Involved?

If you choose to join this study you will:
- Be randomized (like drawing numbers out of a hat) to be 1 one of 8 groups
-- 6 groups will receive hyperbaric oxygen therapy (HBOT)
-- 1 group will receive a high dose of oxygen that is not pressurized
-- 1 group will get standard care
- All groups will complete a follow-up visit (on the phone or in-person) at month 3 and 6 after treatment

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
Protocol Number
IRB: PRO00093798
NCT: NCT02407028
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698