[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587761":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":31,"locations":38,"responsibleParty":59,"collaborators":62,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":36,"enrollmentInfo":75,"targetDuration":36,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":41,"whyStopped":36,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Emory University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Published Biomarker Group","EXPERIMENTAL","Biomarker results are provided to the ED provider immediately and before the decision to order a head CT is made. A print-out of the results will be handed to the provider or uploaded to the epic platform.",[13],"Diagnostic Test: Biomarker Testing using the Alinity Whole-blood TBI biomarker i-STAT",{"label":15,"type":16,"description":17,"interventionNames":18},"Blinded Biomarker Group","ACTIVE_COMPARATOR","Biomarker results are not disclosed during the decision-making process for cranial imaging.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DIAGNOSTIC_TEST","Biomarker Testing using the Alinity Whole-blood TBI biomarker i-STAT","The i-STAT TBI cartridge is a point-of-care, whole-blood, biomarker-based assay that measures the level of biomarkers associated with brain injury in the bloodstream 24 hours after injury. Blood samples (5-10cc of whole blood) will be collected upon admission during a routine blood drawing in the ED. These samples will be tested using the iSTAT system for mild TBI biomarkers.\n\nIn a subset of admitted patients, serial blood draws and iSTAT testing will be performed at 4, 8, 16, and 24 hours, depending on the patient's length of stay.",[15,9],[26],"i-STAT TBI",[28],{"name":29,"affiliation":5,"role":30},"Jonathan Grossberg, MD","PRINCIPAL_INVESTIGATOR",[32],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Ali Tfaily, MS","CONTACT","404-616-1000",null,"ali.tfaily@emory.edu",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Grady Health System","RECRUITING","Atlanta","Georgia","30303","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-84.38798,33.749,{"lat":51,"lon":50},[54,56],{"name":55,"role":34,"phone":35,"phoneExt":36,"email":37},"Ali Tfaily",{"name":57,"role":58,"phone":36,"phoneExt":36,"email":36},"Ali Alawieh, MD PhD","SUB_INVESTIGATOR",{"type":30,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"Jonathan A. Grossberg","Professor of Surgery",[63],{"name":64,"class":65},"Abbott","INDUSTRY","100587761","biomarker-role-in-assessing-imaging-needs-for-mild-cranial-trauma-100587761",false,"NCT06932588","Biomarker Role in Assessing Imaging Needs for Mild Cranial Trauma","BRAIN-CT","Inclusion Criteria:\n\n* Adults aged 18 years and older\n* Mild TBI, defined as Glasgow Coma Scale (GCS) score 13-15, presenting within 24 hours of injury\n* No prior head imaging for the same incident\n* Presenting within 24 hours of onset of injury\n\nExclusion Criteria:\n\n* Patients with penetrating head injury\n* History of known brain abnormality including tumor, cerebrovascular malformation, recent brain surgery (within 6 months), prior head injury (within 6 months)\n* Need for emergent surgical intervention for brain or alternate body organ injury\n* Need for emergent bedside procedures for hemodynamic or orthopedic stabilization\n* Patients deemed at higher risk for decline by the provider prohibit the 15-minute delay in obtaining imaging needed for biomarker testing.","ALL","18 Years",{"count":76,"type":77},350,"ESTIMATED","INTERVENTIONAL",[80],"NA","This study aims to determine whether a blood test can help doctors decide when to use a head CT scan for patients with a mild head injury. Researchers are investigating whether the results from this blood test can aid in making better decisions about patient care and potentially reduce the need for imaging.\n\nIn this study, researchers will collect blood samples to assess whether this specific blood test can help doctors decide when head imaging is necessary following a head injury. The goal is to determine whether the use of this test can reduce the number of head imaging procedures performed in the emergency department (ED).",[83,84],"Brain Injuries","Head Injury",[86,87,88,89,90],"Biomarkers","Brain imaging","Brain trauma","Head CT scan","Mild traumatic brain injury (mTBI)","2025-12-09",{"date":93,"type":94},"2025-12-15","ACTUAL",{"date":96,"type":94},"2025-05-31",{"date":98,"type":77},"2026-06",{"name":5,"class":6},1]