Traumatic Brain Injury Trial
Below is information regarding this EFIC study. Should you wish to participate, take our survey!
What is Boost-3?
BOOST-3 is a research study aimed to determine which 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.
Who Will Be Included?
People who are 14 years old or older with a
Blunt closed head injury, with
Severe brain injury, and
Can start the study immediately following brain monitor placement.
Those that meet the above criteria will be randomly assigned into one of the following study groups:
Intracranial Pressure Alone (ICP)
Medical care based on monitoring the pressure in the brain.
ICP and Brain Tissue Oxygen (PBtO2)
Medical care based off of ICP and the amount of oxygen in the brain.
Benefits and Risks
What are the benefits?
As we are unsure about the which treatment is best regarding the aftermath of a TBI, an individual has the potential to benefit by being in one group over the other. From information gathered in this study, individuals who may suffer from TBI in the future may benefit from results discovered in 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
How is BOOST3 Different Than Other Studies?
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.
What if I Don’t Want to Participate in BOOST3?
Autonomy is something that we take very seriously and in this study. If you do not want to be considered for participation in BOOST3, contact us to request an “Opt Out” medical alert bracelet 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. A link to the “Opt Out” request survey can be found below.
Links
Siren Network
Click to learn more about the SIREN Network
ClinicalTrials.gov
Learn about Boost-3 Study through ClinicalTrials.gov
Video
This video from The University of Washington can provide you more information on the BOOST-3 Study.