Predicting severe traumatic brain injury events

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to develop a computerized method to predict severe traumatic brain injury (TBI) events, specifically episodes of intracranial hypertension and brain tissue hypoxia, before they occur. By analyzing physiologic data from TBI patients, the study utilizes machine-learning algorithms to identify patterns that precede these critical events. The first phase focuses on establishing the necessary informatics infrastructure, while the second phase involves real-time testing of predictions in patients. The goal is to enable timely clinical interventions that could prevent further brain damage.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients age \>18 years old
* Severe TBI, determined by initial Glasgow Coma Scale (GCS) score after resuscitation and without the influence of paralytics or sedation, (GCS score ≤8, motor score ≤5, not following commands)
* The clinical need for ICP and/or PbtO2 monitoring according to the BTF guidelines
* Be able to enroll during the course of their stay in the ICU

Exclusion Criteria:

* Neurological exam suggesting imminent brain death (bilateral, fixed and dilated pupils) or questionable accuracy of the neurologic exam (high blood alcohol level and/or seizure activity \< 30 minutes of exam)
* Evidence of pregnancy (urine or blood test)
* Placement of intracranial monitoring is contraindicated (e.g., uncorrected coagulopathy, depressed skull fracture)
* Inability to obtain informed consent from legal authorized representative (LAR) prior to research procedures
* Participation in another interventional clinical trial (coenrollment with the BOOST3 (CIRB19-0228) trial is allowed\*)
* Prisoner

Where it's running

• University of Chicago
  Chicago, Illinois, United States Recruiting
• Baylor college of medicine
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Christos Lazaridis, MD — clazaridis@bsd.uchicago.edu
• Study coordinator: Farima Fakhri, MD
• Email: Farima.Fakhri@bsd.uchicago.edu
• Phone: 7737021220

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.