Learn about a study of emergency care in patients with traumatic brain injury.

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Please answer a few questions to see if you may qualify.
Have questions? Please contact the study coordinator Revati Vishwasrao at hs-boost3@ucdavis.edu or call (916) 734-4980
By clicking "Next", you're consenting to participate in this questionnaire. There are no right or wrong answers and everything you enter is confidential.
  1. *1. First, please read about the research.
    This study will determine if either of two alternative strategies for monitoring and treating patients with severe brain trauma in the emergency department and critical care unit is more likely to help them get better. It is currently unknown if one strategy is better than the other. In this study, half of the patients will receive a treatment protocol based on brain pressure monitoring alone and the other half with a combination of brain pressure and brain oxygen monitoring. All patients will be managed by a strategy within the standard range of care at this hospital. Consistent with federal research regulations for emergency studies, patients will be enrolled in this study even though they will be unconscious and unable to consent to participation. Patient’s will be enrolled with an exception from consent if a family member or other representative is not available before the treatment must begin.

    Do you understand what this study is about?
  2. *2. Have you or has anyone you personally know experienced a traumatic brain injury?
    (check all that apply)
  3. *3. Please tell us how much you agree
    BOOST3 is an important study to do.
  4. *4. Please tell us how much you agree
    If you had a traumatic brain injury, you would be okay with being included in BOOST3 without giving your consent ahead of time.
  5. *5. Please tell us how much you agree
    If you are/were a parent, and your child had a traumatic brain injury, you would be okay with him/her being included in BOOST3 without giving your consent ahead of time.
  6. *6. Please select one
    Do you think that BOOST3 researchers will seriously consider what community members like you have to say about this study before starting it?
  7. *7. Please select one
    Do you feel that you have been given enough information to give your informed opinion about whether you think it is ok for researchers to do the BOOST3 study?
  8. 8. What additional information would you still like to know?
  9. *9. Would you like to tell doctors that you do not want to participate in BOOST3?
  10. *10. What is your age in years?
  11. *11. Are you Male or Female?
  12. *12. Are you Hispanic or Latino?
  13. *13. Which one or more of the following would you say is your race:
    (Check all that apply)
  14. *14. What is the highest grade or year of school you completed?
  15. 15. Please provide below, any additional comments, concerns or questions you would like to share with the BOOST3 study team:
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Age: 14 and older
Gender:
Any
Healthy Volunteers: Yes
Keywords: Traumatic Brain Injury, TBI, Severe, Head, Trauma, Brain, Brain Oxygen
Type: Interventional
Investigator:
Description
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.
This study requires

• All participants will have both an ICP monitor and a PbtO2 oxygen monitor placed.

• Participants will have an equal chance (like the flip of a coin) of being allocated to one of the two groups. The groups determine which information about the brain will be used to guide medical care.

o Group 1: medical care guided by ICP monitoring (the PbtO2 monitor is covered and not used)

o Group 2: medical care guided by ICP and PbtO2 monitoring

• This random (like the flip of a coin) allocation to one group or another is research.

• Medical care of the participant will be guided by this group allocation (which group the participant is in) for 5 days.Information is collected for the study from participants’ medical record, diagnostic images, and monitors. Information collected includes the condition of the patient and the treatments being provided.

• We will call participants (or their caregivers) about 5 times after their injury. We will call about once each month for 5 months. Each phone call will last about 15 minutes. During the phone call, we will ask how they are doing, if they are having any additional problems, and if any of their contact information has changed.

• We will ask the participant to come in for a study visit about 6 months after their brain injury. If they are not well enough to travel, a member of the study team can visit them where they are living, if they agree. The visit will take about 1 hour. During the visit, a study team member will ask questions about the participant’s recovery. There will be a questionnaire and some pencil and paper exercises.

Who can participate

● 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:

● 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).

Benefits and risks of participating
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.

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
Compensation
There is no payment or compensation for being in the study.
Resources
Schedule
Study duration and period
6 Months
Recruitment period
From Feb. 26, 2019
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Revati Vishwasrao

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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