Brain Oxygen Optimization in Severe TBI, Phase 3 (NCT03754114)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (16 items).
Location: Cedars-Sinai Medical Center — Los Angeles, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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 \< 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (51 Sites)
- Cedars-Sinai Medical Center — Los Angeles, California
- Ronald Reagan UCLA Medical Center — Los Angeles, California
- Stanford University Medical Center — Palo Alto, California
- UC Davis Medical Center — Sacramento, California
- San Francisco General Hospital — San Francisco, California
- University of Colorado Hospital — Aurora, Colorado
- Yale New Haven Hospital — New Haven, Connecticut
- UF Health Shands Hospital — Gainesville, Florida
- Grady Memorial Hospital — Atlanta, Georgia
- The Queen's Medical Center — Honolulu, Hawaii
- University of Chicago Medical Center — Chicago, Illinois
- St. Vincent Hospital — Indianapolis, Indiana
- Maine Medical Center — Portland, Maine
- University of Maryland Medical Center — Baltimore, Maryland
- Johns Hopkins Hospital — Baltimore, Maryland
- Brigham and Women's Hospital — Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts
- UMASS Memorial Medical Center — Worcester, Massachusetts
- University of Michigan — Ann Arbor, Michigan
- Detroit Receiving Hospital — Detroit, Michigan
- Henry Ford Hospital — Detroit, Michigan
- Regions Hospital — Saint Paul, Minnesota
- Cooper University Hospital — Camden, New Jersey
- University of New Mexico Hospital — Albuquerque, New Mexico
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.