Brain Oxygen Optimization in Severe TBI, Phase 3 (BOOST3)
Brain Injuries, Traumatic
About this trial
This is an interventional treatment trial for Brain Injuries, Traumatic focused on measuring intracranial pressure, hypoxia, brain, critical care, emergency treatment, monitoring, physiologic
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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 < 200
- 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
Sites / Locations
- Ronald Reagan UCLA Medical CenterRecruiting
- Stanford University Medical CenterRecruiting
- UC Davis Medical CenterRecruiting
- San Francisco General HospitalRecruiting
- University of Colorado HospitalRecruiting
- Yale New Haven HospitalRecruiting
- UF Health Shands HospitalRecruiting
- University of Chicago Medical CenterRecruiting
- Maine Medical CenterRecruiting
- Massachusetts General HospitalRecruiting
- Beth Israel Deaconess Medical CenterRecruiting
- UMASS Memorial Medical CenterRecruiting
- Detroit Receiving HospitalRecruiting
- Henry Ford HospitalRecruiting
- Regions HospitalRecruiting
- Cooper University HospitalRecruiting
- University of New Mexico HospitalRecruiting
- North Shore University HospitalRecruiting
- Strong Memorial HospitalRecruiting
- University of North Carolina Medical CenterRecruiting
- Duke University HospitalRecruiting
- University of Cincinnati Medical CenterRecruiting
- OSU Wexner Medical CenterRecruiting
- Riverside Methodist HospitalRecruiting
- Oregon Health & Science University HospitalRecruiting
- Penn Presbyterian Medical CenterRecruiting
- Thomas Jefferson University HospitalRecruiting
- UPMC Presbyterian HospitalRecruiting
- Memorial Hermann Hospital
- Ben Taub General HospitalRecruiting
- University of Utah HealthcareRecruiting
- Harborview Medical CenterRecruiting
- WVU Healthcare Ruby Memorial HospitalRecruiting
- Froedtert HospitalRecruiting
- CIUSSS-NIM Hopital du Sacre - Coeur de MontrealRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
ICP only
ICP + PbtO2
ICP guided management strategy: Care in the ICU of research participants randomized to this arm will be guided by a monitoring and treatment strategy in which doctors try to prevent high intracranial pressure (ICP) caused by a swollen brain. This strategy is one of two alternative strategies that is currently used in standard care of patients with traumatic brain injury.
ICP + PbtO2 guided management strategy: Care in the ICU of research participants randomized to this arm will be guided by a monitoring and treatment strategy in which doctors try to prevent high intracranial pressure (ICP), and also try to prevent low PbtO2 (brain tissue oxygen levels). This strategy is one of two alternative strategies that is currently used in standard care of patients with traumatic brain injury.