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Clinical trialNCT03754114Active, not recruitingInterventional

Brain Oxygen Optimization in Severe TBI, Phase 3

SponsorUniversity of MichiganEnrollment1,094Brain Injuries, Traumatic
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

  • Lori Shutter, MD

    University of Pittsburgh, Pittsburgh, PA 15260

    Principal Investigator
  • Ramon Diaz-Arrastia, MD, PhD

    University of Pennsylvania, Philadelphia, PA 19104

    Principal Investigator
  • Sharon Yeatts, PhD

    Medical University of South Carolina, Charleston, SC 29425

    Principal Investigator
  • William Barsan, MD

    University of Michigan, Ann Arbor, MI 48109

    Principal Investigator

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

51 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada
  • University of Calgary - Foothills Medical Centre

    Calgary, Alberta, Canada

  • St. Michaels Hospital

    Toronto, Ontario, Canada

  • Ciusss-Nim Hopital Du Sacre - Coeur de Montreal

    Montreal, Canada

United States
  • Cedars-Sinai Medical Center

    Los Angeles, California, United States

  • 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

  • Johns Hopkins Hospital

    Baltimore, Maryland, United States

  • University of Maryland Medical Center

    Baltimore, Maryland, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, United States

  • Brigham and Women'S Hospital

    Boston, Massachusetts, United States

  • Massachusetts General Hospital

    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

  • Newyork-Presbyterian Queens Hospital

    Flushing, New York, United States

  • North Shore University Hospital

    Manhasset, New York, United States

  • Nyp Columbia University Medical Center

    New York, New York, United States

  • Strong Memorial Hospital

    Rochester, New York, United States

  • Suny Upstate Medical University

    Syracuse, New York, United States

  • Jacobi Medical Center

    The Bronx, New York, United States

  • University of North Carolina Medical Center

    Chapel Hill, North Carolina, United States

  • Duke University Hospital

    Durham, North Carolina, United States

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, United States

  • Osu Wexner Medical Center

    Columbus, Ohio, United States

  • Riverside Methodist Hospital

    Columbus, Ohio, United States

  • Oregon Health & Science University Hospital

    Portland, Oregon, United States

11 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
28 Aug 2019
Primary completion
1 Nov 2027
Completion
1 Nov 2027
Last update posted
5 May 2026
Registered enrollment
1,094
Registry id
NCT03754114

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.