Predicting severe traumatic brain injury events
Prediction and Prevention of Intracranial Hypertension and Tissue Hypoxia in Severe Traumatic Brain Injury
This study is testing a new computer method to see if it can predict serious brain injury events in patients before they happen, so doctors can act quickly to help prevent more damage.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Chicago Academic / other |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Trial ID | NCT06966713 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with severe TBI, as indicated by a Glasgow Coma Scale score of 8 or less.
Not a fit: Patients who are in imminent brain death or have conditions that contraindicate intracranial monitoring will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce mortality and disability rates associated with severe TBI by allowing for earlier medical interventions.
How similar studies have performed: While this approach is innovative, similar predictive methodologies in critical care settings have shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Chicago, Illinois and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.