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NCT03754114 · ClinicalTrials.gov registry record · NA
Brain Oxygen Optimization in Severe TBI, Phase 3
A NA study of Brain Injuries, Traumatic, sponsored by University of Michigan.
- Recruiting
- Registry status
- NA
- Development phase
- 1,094
- Enrollment target
- 20
- Study locations
NCT03754114 is a NA study of Brain Injuries, Traumatic that is actively recruiting participants, run by University of Michigan. The registered enrollment target is 1,094 participants, above the 204-participant average among 21 other Brain Injuries, Traumatic trials with a reported enrollment target (436% higher). The trial reports 20 study locations across 12 states.
The verdict
NCT03754114, a NA study of Brain Injuries, Traumatic, is actively recruiting participants, sponsored by University of Michigan.
- RECRUITING
- Registry status
- NA
- Development phase
- 1,094 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as NA. The registered enrollment target is 1,094 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 204-participant average among 21 other Brain Injuries, Traumatic trials with a reported enrollment target (436% higher). The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
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.
NCT03754114 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Massachusetts, Maryland.
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.
What interventions are being tested in trial NCT03754114?
The interventions under investigation include: ICP + PbtO2 guided management strategy (OTHER), ICP guided management strategy (OTHER).
Who is sponsoring clinical trial NCT03754114?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.