BOOST-3 NINDS Brain Oxygen Optimization

Summary

This study focuses on patients with severe traumatic brain injury (TBI). The purpose of the study is to compare two ways of treating patients with brain injury. Participants will be randomly assigned to one of two groups. One group will receive medical care based on monitoring of pressure in the brain (intracranial pressure or ICP) alone. The other group will receive medical care based on ICP and the amount of oxygen in the brain. In both strategies, doctors will monitor and modify the medical care provided in order to try to improve some measure of the brain's health. It is not yet known which measure of the brain's health, intracranial pressure or oxygen level, is more important. The study results will help determine whether using both methods is better than using one method alone for the treatment of TBI. Both methods are used in standard care, and monitoring devices are approved by the U.S. Food and Drug Administration (FDA).


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
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Study Location(s)

Beverly

More about this Clinical Trial

Full Title

Brain Oxygen Optimization in Severe Traumatic Brain Injury Phase 3

Details
Disease Type/Condition

Brain Injury

Principal Investigator

Torbati, Sam

Age Group

Both

Phase

III

IRB Number

STUDY00000499

ClinicalTrials.gov ID

NCT03754114

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Brain Injury

Principal Investigator

Torbati, Sam

Age Group

Both

Phase

III

IRB Number

BOOST-3

ClinicalTrials.gov ID

NCT03754114

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?