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Computer predicts brain danger before it strikes

NCT ID NCT06966713

Knowledge-focused Sponsor: University of Chicago Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a computer tool that predicts when the brain is about to swell or run low on oxygen in people with severe traumatic brain injury. About 120 adults in the ICU will be monitored, and the tool's predictions will be checked for accuracy. The goal is to give doctors a heads-up so they can act before permanent damage occurs.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2023

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Traumatic brain injury

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Baylor college of medicine

    RECRUITING

    Houston, Texas, 77030, United States

  • University of Chicago

    RECRUITING

    Chicago, Illinois, 60637, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.