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Procedure

Hyperbaric Oxygen Therapy for Traumatic Brain Injury (HOBIT Trial)

Phase 2

Recruiting

Led By Byron Gajewski, Ph.D.

Research Sponsored by Hennepin Healthcare Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Present with severe TBI, defined as Glasgow Coma Scale (GCS) of 3 to 8

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessment at 6 months

Awards & highlights

HOBIT Trial Summary

This trial is testing different combinations of hyperbaric oxygen treatment to see which is most effective for severe TBI patients.

Who is the study for?

This trial is for people aged 16-65 with severe traumatic brain injury (TBI), defined as a Glasgow Coma Scale score of 3 to 8. They must be able to start treatment within 8-14 hours after admission, depending on whether they've had major surgery like craniotomy. Excluded are those who can't start treatment within 24 hours, have non-TBI related coma, penetrating head injuries, pre-existing neurological diseases, unstable spinal cord injury, fixed coagulopathy or severe hypoxia.Check my eligibility

What is being tested?

The study tests different hyperbaric oxygen treatments for TBI patients. It aims to find the best combination of pressure levels and normobaric hyperoxia that could improve outcomes in future trials. Treatments vary from usual care to several combinations of hyperbaric oxygen at pressures between 1.5 ATA and 2.5 ATA with or without additional normobaric hyperoxia.See study design

What are the potential side effects?

Possible side effects include ear pain due to pressure changes, temporary vision changes, lung collapse if air gets trapped during decompression (rare), fatigue and headaches post-treatment.

HOBIT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My severe brain injury score is between 3 to 8.

HOBIT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessment at 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessment at 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessment at 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Glasgow Outcome Scale Extended (GOS-E)

Secondary outcome measures

Brain tissue partial pressure of oxygen

Duration of ICP elevation

Peak brain tissue oxygen (P02) during HBO treatments

+2 more

HOBIT Trial Design

8Treatment groups

Experimental Treatment

Active Control

Group I: Normobaric Hyperoxia (NBH)Experimental Treatment1 Intervention

Normobaric Hyperoxia (NBH meaning 100% O2 at 1.0 ATA) for 4.5 hours twice a day for 5 days.

Group II: Hyperbaric oxygen (2.5 ATA, no NBH)Experimental Treatment1 Intervention

Hyperbaric oxygen at 2.5 ATA for 1 hour, without NBH. This treatment is administered twice a day for 5 days.

Group III: Hyperbaric oxygen (2.5 ATA + NBH)Experimental Treatment1 Intervention

Hyperbaric oxygen at 2.5 ATA for 1 hour and NBH for 3 hours. This treatment is administered twice a day for 5 days.

Group IV: Hyperbaric oxygen (2.0 ATA, no NBH)Experimental Treatment1 Intervention

Hyperbaric oxygen at 2.0 ATA for 1 hour without NBH. This treatment is administered twice a day for 5 days.

Group V: Hyperbaric oxygen (2.0 ATA + NBH)Experimental Treatment1 Intervention

Hyperbaric oxygen at 2.0 ATA for 1 hour and NBH for 3 hours. This treatment is administered twice a day for 5 days.

Group VI: Hyperbaric oxygen (1.5 ATA, no NBH)Experimental Treatment1 Intervention

Hyperbaric oxygen at 1.5 ATA for 1 hour without NBH. This treatment is administered twice a day for 5 days.

Group VII: Hyperbaric oxygen (1.5 ATA + NBH)Experimental Treatment1 Intervention

Hyperbaric oxygen at 1.5 ATA for 1 hour and NBH for 3 hours. This treatment is administered twice a day for 5 days.

Group VIII: Usual careActive Control1 Intervention

Usual care for severe TBI

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)NIH

1,340 Previous Clinical Trials

649,159 Total Patients Enrolled

Hennepin Healthcare Research InstituteLead Sponsor

90 Previous Clinical Trials

76,977 Total Patients Enrolled

Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) - NetworkUNKNOWN

1 Previous Clinical Trials

511 Total Patients Enrolled

Media Library

Hyperbaric oxygen (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT02407028 — Phase 2

Traumatic Brain Injury Research Study Groups: Hyperbaric oxygen (1.5 ATA, no NBH), Hyperbaric oxygen (2.0 ATA, no NBH), Hyperbaric oxygen (2.0 ATA + NBH), Usual care, Hyperbaric oxygen (1.5 ATA + NBH), Normobaric Hyperoxia (NBH), Hyperbaric oxygen (2.5 ATA, no NBH), Hyperbaric oxygen (2.5 ATA + NBH)

Traumatic Brain Injury Clinical Trial 2023: Hyperbaric oxygen Highlights & Side Effects. Trial Name: NCT02407028 — Phase 2

Hyperbaric oxygen (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02407028 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the current sites for this experiment?

"This research project is being conducted at the University of Maryland in Baltimore, MD and UCSD Medical Center - Hillcrest Hospital in San Diego, CA as well as 11 other sites across the US. Notably, Detroit Receiving Hospital in Detroit, MI is also partaking in this study."

Answered by AI

Is the participant pool for this trial comprised of individuals over 40?

"Prospective participants must be aged 16 or above and below the age of 65 to qualify for this trial."

Answered by AI

What is the aggregate number of individuals participating in this medical trial?

"The medical trial requires 200 eligible participants. Subjects can access the study from University of Maryland in Baltimore, as well as UCSD Medical Center - Hillcrest Hospital in San Diego."

Answered by AI

What risks, if any, are associated with Normobaric Hyperoxia (NBH) treatment?

"The safety of Normobaric Hyperoxia is estimated to be a two, as this is still in the Phase 2 trial stage. There are some studies showing its efficacy but no data yet on how safe it truly can be."

Answered by AI

Are there currently any openings in this trial for individuals seeking treatment?

"Absolutely, clinicaltrials.gov lists this trial as presently recruiting patients that meet certain criteria. This study was initially published on June 25th 2018 and the most recent update took place on August 24th 2021. As of now, 11 medical centres are looking to enrol a total of 200 participants."

Answered by AI

Would I be eligible to join this trial?

"This study is recruiting 200 individuals between the ages of 16 and 65 who have experienced a traumatic brain injury. Furthermore, applicants must meet additional criteria such as displaying evidence of severe TBI (as measured by Glasgow Coma Scale) and initiating hyperbaric oxygen treatment within 8 to 14 hours depending on whether or not they require major surgery."

Answered by AI