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NCT06966713 · ClinicalTrials.gov registry record
Predict Severe Traumatic Brain Injury
A clinical trial of Traumatic Brain Injury, sponsored by University of Chicago.
- Recruiting
- Registry status
- 120
- Enrollment target
- 2
- Study locations
NCT06966713: Recruiting study of Traumatic Brain Injury, sponsored by University of Chicago.
NCT06966713 is a study of Traumatic Brain Injury that is actively recruiting participants, run by University of Chicago. The registered enrollment target is 120 participants, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (57% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06966713, a study of Traumatic Brain Injury, is actively recruiting participants, sponsored by University of Chicago.
- RECRUITING
- Registry status
- 120 participants
- Enrollment target
- 2
- Study locations
Study 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 mont
Primary Outcome
The mRS assesses global disability, ranging from 0 (no symptoms) to 6 (death), with higher scores indicating worse outcomes.
Conditions Studied
Study Locations (2)
Illinois
- University of Chicago - Chicago
Texas
- Baylor college of medicine - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2023-02-20 |
| Est. Completion | 2026-08-31 |
What NCT06966713 shows while recruiting
NCT06966713 is an observational study that tracks outcomes without assigning an intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (57% lower).
The record links to 1 condition, with Traumatic Brain Injury appearing as the primary indexed condition, and to 0 interventions.
NCT06966713 reports a single indexed study location in Illinois, Texas.
Frequently Asked Questions
What is clinical trial NCT06966713 about?
NCT06966713 is a clinical study titled "Predict Severe Traumatic Brain Injury". 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 exceedi...
What is the current status of trial NCT06966713?
This trial is currently recruiting. The enrollment target is 120 participants. The study started on 2023-02-20. Estimated completion is 2026-08-31.
What conditions does trial NCT06966713 study?
This clinical trial studies the following conditions: Traumatic Brain Injury.
Who is sponsoring clinical trial NCT06966713?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06966713 being conducted?
This trial has 2 study locations across Illinois, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Traumatic Brain Injury
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06966713's enrollment target sits among peer trials
120 56th of 171 higher than 113 of 171 other Traumatic Brain Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Traumatic Brain Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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