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: CRC pending, Dr. Chris Robinson (PI)

Enrolling hours: M-F 8-5PM

Diagnosis: TBI

Inclusion:

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

Exclusion:

  1. Non-survivable injury
  2. Bilaterally absent pupillary response in the absence of paralytic medication
  3. Contraindication to the placement of intracranial probes
  4. Treatment of brain tissue oxygen values prior to randomization
  5. Planned use of devices which may unblind treating physicians to brain tissue hypoxia
  6. Systemic sepsis at screening
  7. Refractory hypotension
  8. Refractory systemic hypoxia
  9. PaO2/FiO2 ratio < 200
  10. Known pre-existing neurologic disease with confounding residual neurological deficits
  11. Known inability to perform activities of daily living (ADL) without assistance prior to injury
  12. Known active drug or alcohol dependence that, in the opinion of site investigator, would interfere with physiological response to brain tissue oxygen treatments
  13. Pregnancy
  14. Prisoner
  15. On EFIC Opt-Out list as indicated by a bracelet or medical alert