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 is Traumatic Brain Injury (TBI)?
Traumatic Brain Injury (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.
Who can take part in this study?
- People who are 14 years or older with a
- Blunt closed head injury, with
- Severe brain injury, and
- Can start the study immediately following brain monitor placement.
People who meet the entry criteria will be randomly entered, like flipping a coin, into one of the two study groups:
How will you get informed consent?
- Those that get medical care based on monitoring of pressure in the brain (intracranial pressure or ICP) alone.
- Those who get medical care based on both ICP and the amount of oxygen in the brain (brain tissue oxygen or PbtO2).
Normally, researchers get permission (consent) before a person can be included in a study. A person with a severe 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. The strategies being studied typically need to start within 2 to 10 hours of injury. 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.
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What If you do not want to be part of this study?
If you decide you don’t want to be included in the event you suffer a future TBI, email us at email@example.com to request an Opt Out medical alert bracelet be sent to you to wear with the words “BOOST3 declined”. Wearing this medical alert bracelet at all times throughout the study period (about 5 years), is your way of communicating your wishes in case you suffer a severe TBI and are unconscious. If you do not participate in the study, you will receive the standard medical treatment provided for traumatic brain injuries at the hospital in your community.