Brain Oxygen Optimization in Severe TBI, Phase 3 (NCT03754114)
Brain Oxygen Optimization in Severe TBI (BOOST3): A Comparative Effectiveness Study to Test the Efficacy of a Prescribed Treatment Protocol Based on Monitoring the Partial Pressure of Brain Tissue Oxygen.
🩺 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: Review the eligibility criteria below.
Location: Cedars-Sinai Medical Center — Los Angeles, California
Age range: 14 Years
🧪 Interventions in This Study
- ICP + PbtO2 guided management strategy (OTHER)
- ICP guided management strategy (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (51 Sites)
Showing the first 25 of 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.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.