The Systemic Nature of Severe Traumatic Brain Injury
ConditionSevere Traumatic Brain Injury
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorCorewell Health West
About this trial
Severe Traumatic brain injury (sTBI) is a very serious problem, and right now, doctors don't have special treatments to help stop additional injury. Previous studies showed that when a young person gets this kind of brain injury, their body's defense system reacts quickly and strongly. This can cause problems with the brain's protective barrier breaking down and the body making antibodies that attack its own cells. We think that changes in how the brain and the gut (the part of your body that digests food) talk to each other might make these defense reactions stronger. This study wants to figure out exactly how brain injuries change the gut and how that affects the body's defenses. To do this, we will use new ways to study body chemicals and genes \[RNA, cell free DNA (cfDNA) and blood chemistry\] to help us learn why the body reacts this way and how it can lead to more brain injuries and problems in adults with serious brain injuries.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
All patients must be between the ages of 18 to 65 at time of enrollment
Study group cohort will consist of at least 20 patients admitted with severe TBI, defined as a GSC less than or equal to 8 with evidence of intracranial pathology on imaging.
Trauma control cohort will include at least 10 patients matched on demographics and injury patterns without traumatic brain injury.
Healthy control cohort will be comprised of 10 patients without acute traumatic injury or illness, matched to the sTBI patients based on demographics and medical comorbidities.
Disqualifiers
Pregnant Patients
Prisoners
Patients less than 18 years of age or greater than 65 years of age
Patients with a penetrating brain injury mechanism, known neurodegenerative or psychiatric disorders, prior known traumatic brain injury, intracranial neoplasm, patients receiving massing transfusion or blood products prior to arrival, terminal illness or not expected to survive, confirmed or suspected brain death, known autoimmune or immunological condition, receiving immunosuppressant or immunomodulatory therapies, having a cardiac event leading to the injury, or for whom consent is unable to be obtained.
Trial population
Patients diagnosed with sTBI as defined as a Glascow Coma Scale (GCS) of 8 or less
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
40 Participants
are grouped into 2 trial groupsGroup A: Study Group
Group B: Trauma Control
Trial outcomes
Primary outcomes
1
Systemic immune and metabolic responses after sTBI
Characterize the circulating cellular transcriptome using Bulk RNA-seq and single-cell RNA sequencing ScRNA-seq, compared to trauma and healthy controls to identify circulating cell types, clonal activity, and antibody formation that contribute to injury progression.
Time frame
Time of injury and 1-month2
Identifying the mechanisms of immune activation driving secondary injury
Define barrier disruption by performing both the 1H NMR and LC-MS metabolomic analysis (global, targeted, and lipidomics), transcriptomics, and proteomics to measure gut and blood-brain barrier permeability and markers of inflammation and neurodegeneration. Pinpoint cell types, pathways, and antibody-mediated mechanisms contributing to progressive brain injury by integrating transcriptomic and metabolomic datasets.
Time frame
1 year3
Establishment of a biorepository for future biomarker discovery and data integration with the sTBI patient registry for long-term follow-up.
Bank stool and oral flora samples to study gut dysbiosis and investigate the link between gut microbiome and TBI and longitudinal downstream metabolic consequences leading neurodegeneration and psychiatric pathologies· Bank bronchoalveolar lavage (when available), and plasma for additional future ScRNA analyses at defined timepoints. Establish longitudinal outcomes by leveraging a newly developed sTBI registry to follow patients over time, linking early immune and barrier changes with long-term risk of neurodegeneration.
Time frame
1 yearLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Corewell Health West
Lead sponsor
Corewell Health East
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: