Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Brain Oxygen Optimization in Severe TBI, Phase 3
NCT03754114 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- OTHER ICP + PbtO2 guided management strategy
- OTHER ICP guided management strategy
Study Locations (20)
California
- Cedars-Sinai Medical Center — Los Angeles
- Ronald Reagan UCLA Medical Center — Los Angeles
- Stanford University Medical Center — Palo Alto
- UC Davis Medical Center — Sacramento
- San Francisco General Hospital — San Francisco
Massachusetts
- Brigham and Women's Hospital — Boston
- Massachusetts General Hospital — Boston
- Beth Israel Deaconess Medical Center — Boston
- UMASS Memorial Medical Center — Worcester
Maryland
- University of Maryland Medical Center — Baltimore
- Johns Hopkins Hospital — Baltimore
Colorado
- University of Colorado Hospital — Aurora
Connecticut
- Yale New Haven Hospital — New Haven
District of Columbia
- MedStar Washington Hospital Center — Washington D.C.
Florida
- UF Health Shands Hospital — Gainesville
Georgia
- Grady Memorial Hospital — Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,094 participants |
| Start Date | 2019-08-28 |
| Est. Completion | 2027-11-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03754114
The ClinicalTrials.gov registry entry for NCT03754114 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,094 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,126 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Brain Injuries, Traumatic appearing as the primary indexed condition, and to 2 interventions — of which ICP + PbtO2 guided management strategy is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03754114 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Massachusetts, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03754114 about?
NCT03754114 is a clinical study titled "Brain Oxygen Optimization in Severe TBI, Phase 3". 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 o...
What is the current status of trial NCT03754114?
This trial is currently recruiting. It is a NA study. The enrollment target is 1,094 participants. The study started on 2019-08-28. Estimated completion is 2027-11-01.
What conditions does trial NCT03754114 study?
This clinical trial studies the following conditions: Brain Injuries, Traumatic. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03754114?
The interventions under investigation include: ICP + PbtO2 guided management strategy (OTHER), ICP guided management strategy (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03754114?
This trial is sponsored by University of Michigan, which has 1,126 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03754114 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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