Predict Severe Traumatic Brain Injury

NCT06966713 | Recruiting

• 2 other identifiers: IRB22-0871W81XWH22C0058
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (3)

• Modified Rankin Scale (mRS)

  The mRS assesses global disability, ranging from 0 (no symptoms) to 6 (death), with higher scores indicating worse outcomes.

  3, 6, and 12 months post-discharge

• Rivermead Post-Concussion Symptoms Questionnaire (RPQ)

  The RPQ evaluates post-concussion symptoms across physical, cognitive, and emotional domains. Higher scores indicate greater symptom burden.

  3, 6, and 12 months post-discharge

• Glasgow Outcome Scale-Extended (GOSE)

  The GOSE assesses functional outcome after TBI, ranging from 1 (death) to 8 (upper good recovery). Higher scores indicate better recovery.

  3, 6, and 12 months post-discharge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Traumatic brain injury patients admitted to University of Chicago or Baylor College of Medicine

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead
• United States Department of Defense: collaborator
• Baylor College of Medicine: collaborator

Study Sites (2)

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Baylor college of medicine

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Christos Lazaridis, MD

  clazaridis@bsd.uchicago.edu

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Farima Fakhri, MD

CONTACT

7737021220; Farima.Fakhri@bsd.uchicago.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: May 13, 2025
• Study Start: February 20, 2023
• Primary Completion (Estimated): July 13, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: November 10, 2025

Record last verified: 2025-10

Locations

US (2)