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Predict Severe Traumatic Brain Injury

Prediction and Prevention of Intracranial Hypertension and Tissue Hypoxia in Severe Traumatic Brain Injury

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a computer tool that predicts harmful pressure or low oxygen in the brain before they happen. It is for adults over age 18 with a severe brain injury caused by trauma. Patients will receive standard care, with no extra treatments for the study.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be older than 18.
  • Have a severe brain injury after emergency care, with no effects from drugs that cause sleep or stop movement. The Glasgow Coma Scale, which measures responses, must be 8 or lower, with a movement score of 5 or lower and no ability to follow commands.
  • Need monitoring of pressure inside the skull, oxygen in brain tissue, or both, based on brain injury care guidelines.
  • Be able to join during a stay in the intensive care unit (ICU).

Who can't join

  • Have an exam suggesting brain death may happen soon, with both pupils wide and not reacting to light.
  • Have an exam that may be unreliable because of a high blood alcohol level or a seizure within 30 minutes of the exam.
  • Have a positive pregnancy test.
  • Cannot safely have a monitor placed inside the skull, such as because of an untreated blood-clotting problem or a skull fracture pushed inward.
  • Cannot get consent from a legally authorized person before study procedures begin.
  • Be in another study testing a treatment, except the BOOST3 trial, which is allowed.
  • Be a prisoner.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (2)

IL

TX