Learn more about BOOST-3, a study at UNC Medical Center and over 40 sites across the United States.
BOOST-3 is a nationwide NIH research study to learn if either of two strategies for monitoring and treating patients with a severe traumatic brain injury (TBI) in the intensive care unit (ICU) is more likely to help them get better.
Both alternative strategies are used in standard care treatment of TBI. 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 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 ICP alone. The results of this study will help doctors discover if one of these methods is more safe and effective.
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. The strategies being studied typically need to start within 2 to 10 hours of injury and are considered standard care. 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.
Exception from informed consent (EFIC) for emergency research refers to a special set of rules used by the US government to regulate studies when research participants cannot tell researchers their desires in a medical emergency. These special rules allow research studies in certain emergency situations to be conducted without consent.
EFIC can only be used when:
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.
The different treatment strategies may affect:
Brain probes may involve risks of bleeding or infection
Risks of participating in research include breaches of confidentiality.
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 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.