Brain Tissue Oxygen Monitoring in Traumatic Brain Injury
Informed consent is the process where the researchers share key facts about a research study with a person to help them decide whether or not to take part in the research study. Taking part in research is voluntary and people have the right to refuse to take part in a research study. In some emergency situations, people who are taking part in a research study are not able to give their consent due to their condition. The BOOST3 is a research study in which patients may be included in the study without their consent.
What is the purpose of this research study?
BOOST3 is a research study to compare two strategies for monitoring and treating patients with traumatic brain injury in the intensive care unit.
- Medical care based on monitoring of pressure in the brain (intracranial pressure or ICP).
- Medical care based on ICP and the amount of oxygen in the brain (brain tissue oxygen or PbtO2).
It is not known if monitoring 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 including brain tissue oxygen monitoring for patients with TBI will improve their neurological outcomes at 6 months after the injury.
To be eligible for enrollment, patients must present at one of our participating hospital Emergency Departments (ED) and meet the following general enrollment criteria:
- 14 years or older with a
- Blunt closed head injury, with
- Severe brain injury, and
- Can start the study immediately following brain monitor placement.
What will happen in the research study?
Treatment for each group is different. In group 1, doctors make decisions based on
- Types of medications given
- Doses of medications given
- Amount of fluids given by vein
- Ventilator (breathing machine) settings
- Blood transfusions
- Other treatment decisions.
Intracranial pressure and blood oxygen are monitored by small sensors placed in the brain through one or two small holes made in the skull. These sensors are usually placed in the brain soon after the patient arrives at the hospital. Patients who are enrolled in this study will have two sensors placed in their brain.
What are the risks of taking part in this study?
This study will enroll patients with severe traumatic brain injury. These patients have serious health outcomes. However the two different treatment strategies may pose different risks. The risks of treating low brain oxygen levels are not known.
Why is it not possible to get the patients’ consent before including them in the study?
Normally, researchers get permission before a person can be included in a study. This is called informed consent. During the informed consent
In this study, patients are unconscious and therefore cannot give permission to participate in the study. Researchers will do their best to contact and explain the study to family or legally authorized representative (LAR) and ask for their permission to enter the patient to in the study. However, since emergency care for a patient with severe TBI must start quickly, there might not be enough time to locate and talk to the person’s family member or legal representative about the study. In this situation, a patient with severe TBI might be enrolled in this study without his/her family member or representative providing consent.
When a family member or LAR is located they will be asked to give their permission to continue in the study. If the patient wakes up, researchers will inform the patient about the research study and ask for their consent to continue in the study.
How many patients will be included in this research study?
This research will include 1094 patients at 45 locations across the country. Around 50 patients will be included in the study at UTHealth and Memorial Hermann Hospital.
When will the study start?
We plan to start this research study in Spring 2019 and the study is expected to run for about 5 years. We hope to complete the study by early 2020.
If I do not wish to be included in this research study, how can make my wish known?
If you do not wish to participate in this research study, please email us at firstname.lastname@example.org. We will be happy to provide you with an ‘opt-out’ bracelet that you should wear for the duration of the study.
For more information about this research study, please visit https://siren.network/clinical-trials/boost-3 and https://clinicaltrials.gov/ct2/show/study/NCT03754114 or write to the research team at email@example.com.
For more information about emergency exception from informed consent visit planned emergency research without consent.