This research study aims to develop better ways to predict which patients with severe traumatic brain injury will have the worst outcomes. By identifying these high-risk patients early, doctors hope to provide more targeted and intensive treatment to improve survival and reduce disability.
Key Objective:The trial tests whether new prediction tools can accurately identify patients at highest risk of death or severe disability from traumatic brain injury, potentially allowing for earlier intervention.
Who to Consider:Patients who have recently suffered a severe traumatic brain injury and their families seeking to better understand prognosis and treatment options should consider this study.
Trial Parameters
Eligibility Fast-Check
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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.
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) tr