Status:
RECRUITING
Brain Oxygen Optimization in Severe TBI, Phase 3
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
University of Washington
Conditions:
Brain Injuries, Traumatic
Eligibility:
All Genders
14+ years
Phase:
NA
Brief Summary
BOOST3 is a randomized clinical trial to determine the comparative effectiveness of two strategies for monitoring and treating patients with traumatic brain injury (TBI) in the intensive care unit (IC...
Detailed Description
BOOST3 is a randomized clinical trial to determine the comparative effectiveness of two strategies for monitoring and treating patients with traumatic brain injury (TBI) in the intensive care unit (IC...
Eligibility Criteria
Inclusion
- Non-penetrating traumatic brain injury
- Glasgow Coma Scale (GCS) 3-8 measured off paralytics
- Glasgow Coma Scale motor score \< 6 if endotracheally intubated
- Evidence of intracranial trauma on CT scan
- Able to place intracranial probes and randomize within 6 hours of arrival at enrolling hospital
- Able to place intracranial probes and randomize within 12 hours from injury
- Age greater than or equal to 14 years
Exclusion
- Non-survivable injury
- Bilaterally absent pupillary response in the absence of paralytic medication
- Contraindication to the placement of intracranial probes
- Treatment of brain tissue oxygen values prior to randomization
- Planned use of devices which may unblind treating physicians to brain tissue hypoxia
- Systemic sepsis at screening
- Refractory hypotension
- Refractory systemic hypoxia
- PaO2/FiO2 ratio \< 150
- Known pre-existing neurologic disease with confounding residual neurological deficits
- Known inability to perform activities of daily living (ADL) without assistance prior to injury
- Known active drug or alcohol dependence that, in the opinion of site investigator, would interfere with physiological response to brain tissue oxygen treatments
- Pregnancy
- Prisoner
- On EFIC Opt-Out list as indicated by a bracelet or medical alert
Key Trial Info
Start Date :
August 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
1094 Patients enrolled
Trial Details
Trial ID
NCT03754114
Start Date
August 28 2019
End Date
November 1 2027
Last Update
January 7 2026
Active Locations (54)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095-7436
3
Stanford University Medical Center
Palo Alto, California, United States, 94305
4
UC Davis Medical Center
Sacramento, California, United States, 95817