[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645218":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":15,"centralContacts":19,"locations":10,"responsibleParty":25,"collaborators":28,"id":31,"slug":32,"hasResults":33,"nctId":34,"briefTitle":35,"officialTitle":36,"acronym":37,"eligibilityCriteria":38,"healthyVolunteers":39,"sex":40,"minAge":41,"maxAge":42,"enrollmentInfo":43,"targetDuration":10,"studyType":46,"phases":10,"briefSummary":47,"conditions":48,"keywords":10,"overallStatus":50,"whyStopped":10,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":56,"leadSponsor":58,"locationsCount":10},{"fullName":5,"class":6},"Corewell Health West","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Study Group",null,"The first cohort (Study Group) will consist of at least 20 patients admitted to CH Butterworth Hospital with a severe TBI, defined as a GCS ≤ 8 with evidence of intracranial pathology on imaging.",{"label":13,"type":10,"description":14,"interventionNames":10},"Trauma Control","The second cohort (Trauma Control) will include at least 10 patients matched on demographics and injury patterns without traumatic brain injury (head AIS 0).",[16],{"name":17,"affiliation":5,"role":18},"Elizabeth A Steensma, MD, FACS","PRINCIPAL_INVESTIGATOR",[20],{"name":21,"role":22,"phone":23,"phoneExt":10,"email":24},"Ashley Franklyn","CONTACT","6163914051","Ashley.Franklyn@corewellhealth.org",{"type":18,"investigatorFullName":26,"investigatorTitle":27,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Elizabeth Steensma","Principle Investigator",[29],{"name":30,"class":6},"Corewell Health East","100645218","the-systemic-nature-of-severe-traumatic-brain-injury-100645218",false,"NCT07679126","The Systemic Nature of Severe Traumatic Brain Injury","The Systemic Nature of Severe Traumatic Brain Injury: Multi-Omic Analysis of Neural Trauma, Autoantibodies and the Gut-Brain Axis: The MANTRA Study","MANTRA","Inclusion Criteria:\n\n* All patients must be between the ages of 18 to 65 at time of enrollment\n* 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.\n* Trauma control cohort will include at least 10 patients matched on demographics and injury patterns without traumatic brain injury.\n* 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.\n\nExclusion Criteria:\n\n* Pregnant Patients\n* Prisoners\n* Patients less than 18 years of age or greater than 65 years of age\n* 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.",true,"ALL","18 Years","65 Years",{"count":44,"type":45},40,"ESTIMATED","OBSERVATIONAL","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.",[49],"Severe Traumatic Brain Injury","NOT_YET_RECRUITING","2026-06-25",{"date":53,"type":54},"2026-07-01","ACTUAL",{"date":53,"type":45},{"date":57,"type":45},"2029-07-01",{"name":5,"class":6}]