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Normally, researchers get permission (consent) before a person can be included in a study. A person with a severe traumatic brain injury (TBI) will not be able to give consent at the time of injury. Since TBI must be treated quickly, there might not be enough time to locate and talk to the person's family or legal representative about the study.

When consent is not possible, a person might be enrolled in this study without consent. This is called "Exception from Informed Consent" (EFIC).

Once the family or legal representative is located, they will be asked whether they want the participant to continue in the study. If you decide you don't want to be included in the event you suffer a future TBI, contact us to request an Opt Out medical alert bracelet be sent to you to wear.

Background

TBI is sudden damage to the brain caused by an outside force to the head – such as a car crash, a fall, or something hitting the head.

  • Every 15 seconds someone in the US suffers a major TBI.
  • Every five minutes someone is forever disabled as a result of TBI.
  • TBI is the leading cause of death and disability in children and adults 1-44 years of age.

TBI can affect a person's ability to think and remember things, cause problems with balance and coordination, prevent a person from functioning independently, cause permanent brain damage or even death.

Current EFIC Clinical Trials

HOBIT

HOBIT is a research study to identify the best way to deliver high dose oxygen under pressure (hyperbaric oxygen) so that severe TBI patients can recover with less disability. The word hyperbaric means to increase the pressure around the subject. This feels similar to the pressure a person feels when they dive into a body of water. Hyperbaric oxygen therapy or HBOT is a standard approved therapy for other conditions, but not for subjects with severe TBI. HBOT for TBI is investigational, which means it has not been approved by FDA for use outside of research studies like this one. It is unknown if adding HBOT to standard care is more effective, less effective, or the same as standard care alone.

What are the benefits?

Because we do not know which treatment is best for treating TBI, a person enrolled in the study may benefit from being placed in one study group over the other. Based on the information we get from this study, people who have a TBI in the future may benefit from what is learned from this study.

What are the risks?

Participation in this study carries the following risks which occur infrequently:

  • Pneumonia or lung injury/infection
  • Seizure
  • Ear infection
  • Complications of transport to and from chamber

Risks of participating in research include:

  • Breaches of confidentiality

Study Survey

Share your opinions in this study survey.

You can also view these powerpoint slides about the Hyperbaric Oxygen Brain Injury Treatment (HOBIT) Trial to learn more.

Contact Us

HOBIT Study
University of Maryland
22 S. Greene Street
TBR07A
Baltimore, MD 21201

Phone: 410-328-0288
Email: Lsult@som.umaryland.edu

BOOST3

BOOST3 is a research study to learn if either of two strategies for monitoring and treating patients with TBI in the intensive care unit (ICU) is more likely to help them get better. Both of these alternative strategies are used in standard care. It is unknown if one is more effective than the other.

In one strategy doctors concentrate only on preventing high ICP (intracranial pressure) caused by a swollen brain. In the other strategy doctors try to prevent high ICP, and also try to prevent low PbtO2 (brain oxygen).

It is unknown if measuring and treating low brain oxygen is more effective, less effective, or the same as monitoring and treating high brain pressure alone. The results of this study will help doctors discover if one of these methods is more safe and effective.

What are the benefits?

Because we do not know which treatment is best for treating TBI, a person enrolled in the study may benefit from being placed in one study group over the other. Based on the information we get from this study, people who have a TBI in the future may benefit from what is learned from this study.

What are the risks?

The different treatment strategies may affect:

  • Risk of pneumonia or lung injury
  • Severe infection in the blood or brain

Brain probes may involve risks of

  • Bleeding or infection

Risks of participating in research include:

  • Breaches of confidentiality

Study Survey

Share your opinions on the study in this survey.

You can also view these powerpoint slides about the Brain Oxygen Optimization in Severe Traumatic Brain Injury Community Consultation (BOOST3) to learn more.

Contact Us

BOOST3 Study
University of Maryland
22 S. Greene Street
TBR07A
Baltimore, MD 21201

Phone: 410-328-0288
Email: Bcave@som.umaryland.edu or Lsult@som.umaryland.edu

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