EpiBioS4Rx Inclusion/ Exclusion Criteria

If there are any questions regarding the eligibility of a screened patient, please contact the UCLA Coordinating team via epibios@mednet.ucla.edu

Inclusion Criteria:

  • Acute traumatic brain injured patients with evidence of intracranial, cortical and/or subcortical bleed on CT imaging

  • Age 6-100 are eligible

  • GCS 3-13 without continuous sedation at time of enrollment

  • Ability to enroll within 72 hours of injury

  • Patients with polytrauma including long bone fractures, blunt trauma, abdominal trauma or similar may be enrolled

Exclusion Criteria:

  • Patients with diffuse axonal injury in the absence of hemorrhagic contusions or skull fracture, and isolated epidural hemorrhages that improve after evacuation

  • No plan for continuous EEG monitoring during injury day 1-7

  • Inability to undergo MRI within post injury day 1-18 due to bullet, metal implant, pacemaker, etc.

  • Known HIV/AIDS, Hepatitis B or C

  • Pregnancy

  • Pre-existing Neurologic disease ( e.g. TBI, Stroke, or Neurodegenerative disorder)

  • Pre-existing CNS malignancy

  • Pre-existing epilepsy/seizure disorder

  • Pre-existing dementia

  • Isolated anoxic brain injury

  • Devastating cervical spine injury

  • Brain Death

  • Incarceration present or pending

  • Inability on part of patient or family to complete the study to Day 730

  • Positive SARS-CoV-2 (COVID-19) test

  • Any other condition or situation that the investigator believes may interfere with the safety of the subject or the conduct of the study, to include inability for study completion


Adapted from the EpiBioS4x Protocol V.4.0