Recruiting

Observational Study

Sponsor:

University of Chicago

Code:

NCT06966713

Conditions

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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 the U.S. population lives with disabilities directly attributable to TBI, with annual costs exceeding $76.5 billion.

Current treatments are largely ineffective because they are instituted after irreversible damage has already occurred. By the time intracranial pressure (ICP) increases or brain tissue oxygen tension (PbtO2) decreases to harmful levels, it is often too late to reverse or repair the damage. A computerized method has been developed that can predict these injurious events ahead of time, allowing clinicians to intervene before further damage occurs. The goal of this proposal is to test these predictions in real time.

The first phase of the project (Year 1) involves setting up the informatics infrastructure, with no patient interaction. In the second phase (Year 2), subjects, through surrogate decision-makers, will be enrolled in an observational study where data on intracranial pressure and brain tissue oxygen tension will be collected, and the prediction algorithm will be tested for accuracy. Clinical management will follow standard care protocols, and no additional interventions will be performed.

Approximately 120 individuals will participate in this study at the University of Chicago and Ben Taub General Hospital in Houston. Data collected will include both the electronic medical record and data from bedside intensive care unit monitors. The electronic medical record includes demographic information, injury characteristics, laboratory values, and imaging data, while the intensive care unit monitor provides real-time vital signs such as intracranial pressure, brain tissue oxygen tension, and mean arterial pressure. These data will be securely stored in a research computer database.

Efforts will be made to contact subjects or their caretakers at 6 months to follow up on recovery. This research aims to improve patient outcomes by providing predictions of further brain injury, with the potential for future interventions to prevent permanent brain damage.

Conditions

Traumatic Brain Injury

Study ID

NCT06966713

Start date

Feb 20, 2023

Status verified date

Oct, 2025

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Jul 13, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Modified Rankin Scale (mRS) [ Time Frame: 3, 6, and 12 months post-discharge ]
  • Rivermead Post-Concussion Symptoms Questionnaire (RPQ) [ Time Frame: 3, 6, and 12 months post-discharge ]
  • Glasgow Outcome Scale-Extended (GOSE) [ Time Frame: 3, 6, and 12 months post-discharge ]

Central Contacts and Locations

Central contacts

Locations

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Principal Investigator:

Christos Lazaridis, MD

Baylor college of medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Jose Marcelo Rizzoli Mayans

832-360-7292jose.rizzolimayans@bcm.edu

Principal Investigator:

Jovany Cruz Navarro, MD

More Information

Sponsor

University of Chicago

Last update posted

Nov 10, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Chicago on 2025-11-10.