Brain Oxygen Optimization in Severe TBI, Phase 3

Running, not enrolling · Not applicable

Conditions studied: Brain Injuries, Traumatic

In brief

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 (ICU). The study will determine the safety and efficacy of a strategy guided by treatment goals based on both intracranial pressure (ICP) and brain tissue oxygen (PbtO2) as compared to a strategy guided by treatment goals based on ICP monitoring alone. Both of these alternative strategies are used in standard care. It is unknown if one is more effective than the other. In both strategies the monitoring and goals help doctors adjust treatments including the kinds and doses of medications and the amount of intravenous fluids given, ventilator (breathing machine) settings, need for blood transfusions, and other medical care. The results of this study will help doctors discover if one of these methods is more safe and effective.

Key facts

Study ID

NCT03754114

Run by

University of Michigan

People needed

1094

Starts

2019-08-28

Expected to finish

2027-11-01

Last updated by the study team

2026-05-05

Who can join

Age: 14 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• Stanford University Medical Center — Palo Alto, California, United States
• UC Davis Medical Center — Sacramento, California, United States
• San Francisco General Hospital — San Francisco, California, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• UF Health Shands Hospital — Gainesville, Florida, United States
• Grady Memorial Hospital — Atlanta, Georgia, United States
• The Queen's Medical Center — Honolulu, Hawaii, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• St. Vincent Hospital — Indianapolis, Indiana, United States
• Maine Medical Center — Portland, Maine, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• UMASS Memorial Medical Center — Worcester, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Detroit Receiving Hospital — Detroit, Michigan, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Regions Hospital — Saint Paul, Minnesota, United States
• Cooper University Hospital — Camden, New Jersey, United States
• University of New Mexico Hospital — Albuquerque, New Mexico, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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