[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588348":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":32,"locations":38,"responsibleParty":56,"collaborators":10,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":10,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":10,"maxAge":66,"enrollmentInfo":67,"targetDuration":10,"studyType":70,"phases":10,"briefSummary":71,"conditions":72,"keywords":10,"overallStatus":41,"whyStopped":10,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"University of Nebraska","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1 - Traumatic Brain Injury With Positive Head Computed Tomography Findings",null,"Group 1 will be 110 participants who had a traumatic brain injury (TBI) with positive head computed tomography (HCT).",[13],"Diagnostic Test: Blood Test for Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase L1 (UCH-L1) Acute Biomarkers",{"label":15,"type":10,"description":16,"interventionNames":17},"Group 2 - Traumatic Brain Injury With Negative Head Computed Tomography Findings","Group 2 will be 110 participants with a known traumatic brain injury (TBI), but a negative head computed tomography (HCT).",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Group 3 - All Other Trauma Participants With No History of Head Injury","Group 3 will be 110 participants being treated for a traumatic injury with no history of head injury.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"DIAGNOSTIC_TEST","Blood Test for Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase L1 (UCH-L1) Acute Biomarkers","All groups will have blood drawn per standard of care. Blood samples will be analyzed using Traumatic Brain Injury (TBI) cartridges for iSTAT Alinity device.",[9,15,19],[29],{"name":30,"affiliation":5,"role":31},"Grace Lai, MD, PhD","PRINCIPAL_INVESTIGATOR",[33],{"name":34,"role":35,"phone":36,"phoneExt":10,"email":37},"Megan McChesney, BSN, RN, CPN","CONTACT","531-375-3835","mmcchesney@unmc.edu",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Children's Nebraska","RECRUITING","Omaha","Nebraska","68114","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-95.94043,41.25626,{"lat":51,"lon":50},[54,55],{"name":34,"role":35,"phone":36,"phoneExt":10,"email":37},{"name":30,"role":31,"phone":10,"phoneExt":10,"email":10},{"type":57,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100588348","validating-a-blood-test-for-the-detection-of-traumatic-brain-injury-in-children-100588348",false,"NCT06940232","Validating a Blood Test for the Detection of Traumatic Brain Injury in Children","Ubiquitin C-terminal Hydrolase L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP) as Acute Biomarkers for Prediction of Traumatic Brain Injury (TBI) in Children","Inclusion Criteria:\n\n* 0-17 years of age\n* Presentation of non-penetrating trauma\n* Blood draw within 24 hours of injury\n* For TBI group: head CT or MRI obtained\n\nExclusion Criteria:\n\n* Presentation to Children's Nebraska after 24 hours of injury\n* 18 years of age or older","ALL","17 Years",{"count":68,"type":69},330,"ESTIMATED","OBSERVATIONAL","The primary objective of this study is to establish if Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase L1 (UCH-L1) are predictive of computed tomography (CT) findings in pediatric traumatic brain injuries (TBI). The participant population is pediatric patients, ages 0 to less than 18 years old with a possible TBI or trauma-related injury who have blood drawn per standard of care in the emergency department. Blood samples will be analyzed using the i-STAT TBI cartridge (Abbott Laboratories, Abbott Park, IL, USA) by the Emergency Department charge nurse within one hour of collection of the blood sample. Clinical outcomes will be assessed via telephone interview with a parent at 3 and 6 months for all surviving TBI patients.",[73],"Pediatric Traumatic Brain Injury","2026-08-11",{"date":76,"type":77},"2026-08-14","ACTUAL",{"date":79,"type":77},"2025-05-14",{"date":81,"type":69},"2027-12",{"name":5,"class":6},1]