Status:
RECRUITING
Predict Severe Traumatic Brain Injury
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
United States Department of Defense
Baylor College of Medicine
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18+ years
Brief Summary
Severe traumatic brain injury (TBI) is associated with a 20-30% mortality rate and significant disability among most survivors. The Centers for Disease Control and Prevention (CDC) estimate that 2% of...
Detailed Description
Recently, the investigators achieved prediction of episodes of intracranial hypertension (ICH) and brain tissue hypoxia (BTH) 30 minutes to several hours in advance of overt deterioration using intuit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 20 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06966713
Start Date
February 20 2023
End Date
August 31 2026
Last Update
November 10 2025
Active Locations (2)
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1
University of Chicago
Chicago, Illinois, United States, 60637
2
Baylor college of medicine
Houston, Texas, United States, 77030