[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580235":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":12,"locations":18,"responsibleParty":33,"collaborators":10,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":10,"eligibilityCriteria":43,"healthyVolunteers":39,"sex":44,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":10,"studyType":50,"phases":10,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":57,"whyStopped":10,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":65,"locationsCount":66},{"fullName":5,"class":6},"Università Vita-Salute San Raffaele","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Adult patients with TBI",null,"Adult patients (ages ≥18 and ≤65), conscious and unconscious, presenting to the emergency department with TBI at triage. TBI is defined as trauma caused by an external physical force capable of causing temporary or permanent alterations in consciousness and\u002For neurological function.\n\nPost Market Performance follow-up study: Application of the Abbott i-STAT™ TBI Plasma Test to all cases within 12 hours of cranial trauma for detecting GFAP and UCH-L1 biomarkers.",[13],{"name":14,"role":15,"phone":16,"phoneExt":10,"email":17},"Jody F. Capitanio, MD","CONTACT","+39 02 26433047","capitanio.jodyfilippo@hsr.it",[19],{"facility":20,"status":10,"city":21,"state":22,"zip":23,"country":22,"countryCode":24,"cosmosGeoPoint":25,"geoPoint":30,"contacts":31},"IRCCS San Raffaele","Milan","Italy","20132","IT",{"type":26,"coordinates":27},"Point",[28,29],9.18951,45.46427,{"lat":29,"lon":28},[32],{"name":14,"role":15,"phone":16,"phoneExt":10,"email":17},{"type":34,"investigatorFullName":35,"investigatorTitle":36,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Chiara Di Resta","PhD","100580235","correlation-and-rapid-analysis-of-neurological-injury-using-markers-100580235",false,"NCT06834659","Correlation and Rapid Analysis of Neurological Injury Using Markers","CRANIUM: Post-Market Performance Follow-up Study for the Evaluation of the Presence of Circulating Plasma Brain Biomarkers in Peripheral Blood and Acute Traumatic Brain Injury in Adult Emergency Department Patients.","Inclusion Criteria:\n\n* Patients aged 18 to 65, male and female, presenting to the emergency department due to TBI, defined as trauma caused by an external force leading to temporary or permanent alterations in consciousness and\u002For neurological function. TBI severity is evaluated using the Glasgow Coma Scale (GCS).\n* Sign of informed consent by patient or legal tutor\n\nExclusion Criteria:\n\n* Pediatric patients (\\\u003C18 years).\n* Patients \\>65 years, to avoid potential confounding factors such as elevated GFAP levels associated with Alzheimer's disease.","ALL","18 Years","65 Years",{"count":48,"type":49},200,"ESTIMATED","OBSERVATIONAL","Each year, approximately 69 million people worldwide suffer from traumatic brain injuries (TBI), representing a significant burden on public health, society, and the economy. Timely and accurate care can influence short-, medium-, and long-term outcomes, making the reduction of diagnostic delays crucial. TBI diagnostics require careful consideration, as initial evaluations may differ from final assessments, and patient conditions may evolve over time.\n\nIn this monocentric, observational, post-market follow-up study we aim to evaluate the Abbott i-STAT™ TBI Plasma Test in detecting circulating brain biomarkers (GFAP and UCH-L1) in adult patients with TBI.\n\nThe study involves recruiting 200 adult patients (aged 18-65 years) presenting to the emergency department with TBI over a two-year period. For each participant, a blood sample will be collected as part of routine clinical care and analyzed using the Abbott i-STAT™ TBI Plasma Test within 12 hours of the trauma. The results will be compared with those obtained from cranial CT scans, the gold standard for diagnosing intracranial injuries.\n\nSpecifically, the study aims to assess the diagnostic accuracy of the test in excluding intracranial injuries, particularly in cases of mild TBI, and to explore potential correlations between biomarker presence and injury severity. No additional procedures beyond routine clinical care are required, and all collected data will be used exclusively for the study's predefined objectives.",[53],"Traumatic Brain Injury (TBI) Patients",[55,56],"Biomarkers","traumatic brain injury","NOT_YET_RECRUITING","2026-04-28",{"date":60,"type":61},"2026-04-29","ACTUAL",{"date":63,"type":49},"2027-06",{"date":63,"type":49},{"name":5,"class":6},1]