[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616890":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":27,"locations":33,"responsibleParty":50,"collaborators":10,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":10,"enrollmentInfo":63,"targetDuration":66,"studyType":67,"phases":10,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":35,"whyStopped":10,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Hospital Universitario 12 de Octubre","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Pre-implemetation Mild TBI cohort",null,"Mild TBI patients managed before the implementation of the combined GFAP UCH-L1 test",{"label":13,"type":10,"description":14,"interventionNames":15},"Post-implementation Mild TBI cohort","Prospective Mild TBI patients managed following a clinical pathway including the use of the combined GFAP UCH-L1 diagnostic test in a real world enviroment",[16],"Diagnostic Test: GFAP and UCH-L1",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"DIAGNOSTIC_TEST","GFAP and UCH-L1","Serum test to measure the concentration of GFAP and UCH-L1",[13],[24],{"name":25,"affiliation":5,"role":26},"Alfonso Lagares, MD, PhD","PRINCIPAL_INVESTIGATOR",[28],{"name":25,"role":29,"phone":30,"phoneExt":31,"email":32},"CONTACT","+34913908000","4590","alfonlag@ucm.es",[34],{"facility":5,"status":35,"city":36,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"RECRUITING","Madrid","28041","Spain","ES",{"type":41,"coordinates":42},"Point",[43,44],-3.70256,40.4165,{"lat":44,"lon":43},[47],{"name":25,"role":29,"phone":48,"phoneExt":31,"email":49},"+349138000","alfonso.lagares@salud.madrid.org",{"type":26,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Alfonso Lagares Gómez-Abascal","Professor of Neurosurgery, Head of Department Neurosurgery","100616890","implementation-of-biomarker-based-care-for-mtbi---impacts-braini-study-100616890",false,"NCT07311486","Implementation of Biomarker-Based Care for mTBI - IMPACTS-BRAINI Study","BLOOD BIOMARKERS TO IMPROVE MANAGEMENT OF MILD TRAUMATIC BRAIN INJURY IMPLIMENTACIÓN STUDY","IMPACTS-BRAINI","Inclusion Criteria:\n\n* -All adult patients suffering mild TBI:( Defined by at least criterion a) and d) and one or more of the other criteria)\n\n  1. The presence of a plausible traumatic mechanism observed\u002For related by the patient´s recount of the injury event.\n  2. Presence of one or more clinical signs attributable to brain injury: Loss of consciousness immediately following injury, alteration of mental status immediately following the injury, posttraumatic amnesia or any neurological abnormality.\n  3. At least two acute symptoms related to the injury: feeling confused or disoriented, headache, nausea, vomiting, dizziness, vision problems, memory problems, emotional lability or irritability.\n  4. a GCS between 15 and 13, at least 30 minutes after injury.\n* Blood sample obtained ≤12 h after injury and ideally before any imaging prescription.\n\nExclusion Criteria:\n\n* · GCS 3-12 on admission\n\n  * Age Below 18 years\n  * Time of injury unknown\n  * Time to injury exceeding 12 hours\n  * Primary admission for non-traumatic neurological disorder (e.g., stroke, spontaneous, intracranial hematoma)\n  * Penetrating head trauma\n  * Patient with mechanical ventilation from the trauma scene or prehospital management\n  * Venipuncture not feasible","ALL","18 Years",{"count":64,"type":65},1000,"ESTIMATED","2 Weeks","OBSERVATIONAL","This study aims to evaluate the real-world applicability and clinical added value of a new management pathway for patients presenting to the emergency department (ER) with mild traumatic brain injury (mTBI). The pathway includes the use of the VIDAS® TBI in vitro diagnostic assay, which measures the blood biomarkers GFAP and UCH-L1 within 12 hours of injury to determine whether a CT scan is necessary.\n\nThe study seeks to answer two primary questions:\n\n1. Safety and effectiveness: Whether the VIDAS® TBI test can safely and accurately rule out the need for head CT in mTBI patients in routine emergency care.\n2. Clinical and operational impact: Whether incorporating this test reduces the number of CT scans performed and shortens ER length of stay for patients with mild TBI.\n\nTo assess these outcomes, researchers will compare patient management using the new biomarker-based pathway to a historical cohort of mTBI patients who were managed without the biomarker test.",[70],"Mild Traumatic Brain Injury (mTBI)",[72,73,74,75],"Biomarker","GFAP","UCH-L1","Implementation","2025-12-21",{"date":78,"type":79},"2025-12-31","ACTUAL",{"date":81,"type":79},"2025-07-15",{"date":83,"type":65},"2026-05-01",{"name":5,"class":6},1]