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Department of Neurology College of Medicine
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Acute Neurology Clinical Trials Overview

Traumatic Brain Injury – BOOST3

Name: BOOST3 (Brain Oxygen Optimization in Severe TBI: A Comparative Effectiveness Study to Test the Efficacy of a Prescribed Treatment Protocol Based on Monitoring the Partial Pressure of Brain Tissue Oxygen)

Contact: Dr. Chris Robinson (PI) (304) 646-4613 and Magali Jorand-Fletch (Lead CRC) (352) 294-5391

Enrolling hours: M-F 8-5PM

Diagnosis: TBI

Inclusion:

  1. Non-penetrating traumatic brain injury
  2. Requirement for intracranial pressure monitoring, based on BTF/ACS TQIP Guidelines for the management of severe TBI, as operationalized below:
    • 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
    • If patient has a witnessed seizure, wait 30 min to evaluate GCS
  1. Able to place intracranial monitors and randomize within 6 hours of arrival at enrolling hospital, but no later than 12 hours from injury
  2. Age greater than or equal to 14 years

Exclusion:

  1. Bilaterally absent pupillary response in the absence of paralytic medication
  2. Contraindication to the placement of intracranial probes, such as uncorrectable coagulopathy
  3. Treatment of brain tissue oxygen values prior to randomization
  4. Planned use of devices which may unblind treating physicians to brain tissue hypoxia
  5.  Clinical, demographic, or other characteristics that precludes appropriate diagnosis, treatment, or follow-up
    • Systemic sepsis at screening
    • Refractory hypotension (SBP< 90 mmHg for two consecutive readings at least 15 minutes apart any time prior to randomization)
    • Refractory systemic hypoxia (SaO2 < 90% or FIO2 >0.5 for two consecutive readings at least 15 minutes apart any time prior to randomization)
    • 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
    • Non- survivable injury
    • Pregnancy
    • Prisoner or ward of the state
  6. Patient listed on EFIC opt-out registry for study