BOOST3: Brain Oxygen Optimization in Severe Traumatic Brain Injury, Phase 3
Overview
Researchers at the University of Washington based at Harborview Medical Center are participating in a national study through the Strategies to Innovate Emergency Care Clinical Trials Network (SIREN), to learn if either of two strategies for monitoring and treating patients with traumatic brain injury (TBI) in the intensive care unit (ICU) is more likely to help them get better. Randall M. Chesnut, MD is principal investigator for this clinical study.
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.
Both of the strategies in this study are used in standard care. It is unknown if one is more effective than the other. In one strategy doctors concentrate on preventing high pressure within the head (intracranial pressure – ICP) caused by brain swelling. In the other strategy doctors try to prevent high ICP and also try to prevent low brain oxygen levels (PbtO2). 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 approaches is safer and more effective.
Patients that are eligible for the study
People who are 14 years or older with these 3 criteria:
- Blunt closed head injury
- Severe brain injury
- 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:
- A group that gets medical care based on monitoring of pressure in the brain (intracranial pressure – ICP) alone.
- A group who gets medical care based on both ICP and the amount of oxygen in the brain (brain tissue oxygen – PbtO2).
What it means to participate in the study
All study patients will receive state-of-the-art treatment, regardless to which group they have been randomized. In addition, they will be followed for outcome at three and six months for study purposes. Because we don’t know which treatment is best, a person in the study may benefit from being in one group (if there turns out to be a difference in outcomes between the groups). Information gained from this study should benefit people suffering a TBI in the future based on improvements in our scientific knowledge of management techniques.
Enrollment in this study
In general, investigators must obtain permission (consent) from the individual or their legal representative before they can be enrolled in a scientific study. Because TBI is an emergency and must be treated as soon as possible, investigators may not have time to contact the patient’s family or legal representative. Based on thorough scientific and ethical review of the BOOST3 study, and following a period of public comment, this study has been granted Exception From Informed Consent (EFIC), which allows eligible patients to be enrolled without consent. Every effort will be made to locate family or legal representatives as soon as possible and ask them if they want to allow continued participation in this study.
EFIC
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:
- The person’s life is at risk, AND,
- The best treatment is not known, AND
- The study might help the person, AND
- It is not possible to get permission:
- from the person because of his or her medical condition nor
- from the person’s representative because there is a very short amount of time required to treat the medical problem, or the representative is not available.
If you do not want to be involved in this study
Persons who decide that they do not wish to be part of this study should they suffer a severe TBI in the future can opt out. They can demonstrate this decision by wearing a bracelet that reads “NO STUDY.” The bracelet indicates that, should you be injured, medical care providers will exclude you from the research. If you choose not to be involved in this study, you will receive standard TBI care.
Key study dates and locations
- The study is estimated to conclude in 2027.
- Harborview Medical Center is currently one of the study locations and is recruiting.
If you have questions or would like additional information about this study, please contact:
The Research Team at 206.897.1779 or email: boost3@uw.edu.
We will attempt to return e-mails and calls during business hours. We will not keep any personal information you provide, nor will we share any of your personal information with anyone.
The National Library of Medicine description of the BOOST 3 study is available at ClinicalTrials.gov