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Comparing two methods for monitoring brain oxygen in severe traumatic brain injury

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.

Not applicable Interventional University of Michigan · NCT03754114

This study is testing two different ways to monitor brain oxygen levels in patients with severe traumatic brain injury to see which method helps them get better and stay safer in the ICU.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment1094 (estimated)
Ages14 Years and up
SexAll
SponsorUniversity of Michigan Academic / other
Locations48 sites (Los Angeles, California and 47 other locations)
Trial IDNCT03754114 on ClinicalTrials.gov

What this trial studies

BOOST3 is a randomized clinical trial designed to evaluate the effectiveness of two different strategies for monitoring and treating patients with traumatic brain injury (TBI) in the intensive care unit. One strategy focuses on both intracranial pressure (ICP) and brain tissue oxygen (PbtO2) levels, while the other relies solely on ICP monitoring. The study aims to determine which approach is safer and more effective in managing TBI patients by adjusting treatments based on the monitored parameters. Both monitoring techniques are FDA-approved and commonly used in clinical practice, but their comparative effectiveness remains unclear.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 14 and older with non-penetrating traumatic brain injuries and a Glasgow Coma Scale score between 3 and 8.

Not a fit: Patients with non-survivable injuries or those with contraindications to intracranial probe placement may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment protocols for patients with severe traumatic brain injuries, potentially enhancing recovery outcomes.

How similar studies have performed: While both monitoring strategies are commonly used, this study is novel in its direct comparison of their effectiveness in a randomized setting.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Non-penetrating traumatic brain injury
* Glasgow Coma Scale (GCS) 3-8 measured off paralytics
* Glasgow Coma Scale motor score \< 6 if endotracheally intubated
* Evidence of intracranial trauma on CT scan
* Able to place intracranial probes and randomize within 6 hours of arrival at enrolling hospital
* Able to place intracranial probes and randomize within 12 hours from injury
* Age greater than or equal to 14 years

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
* Known active drug or alcohol dependence that, in the opinion of site investigator, would interfere with physiological response to brain tissue oxygen treatments
* Pregnancy
* Prisoner
* On EFIC Opt-Out list as indicated by a bracelet or medical alert

Where this trial is running

Los Angeles, California and 47 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Brain Injuries, Traumaticintracranial pressurehypoxia, braincritical careemergency treatmentmonitoring, physiologic
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.