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NCT07455136
A Study to Develop a Blood-based Test for Aiding the Diagnosis/Prognosis of Traumatic Brain Injury in Adults and for Monitoring the Development of Secondary Events in Patients Diagnosed With Traumatic Brain Injury
Conditions: Traumatic Brain Injury
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 2000
Sponsor: Hoffmann-La Roche
Location: University Of California Davis, Neurological Surgery Sacramento California
Summary
The study is intended to cover two purposes: first, to develop a blood-based biomarker test for aiding the diagnosis of traumatic brain injury (TBI) in adult participants and for prognosis of outcome of TBI (CLIN12.1); and second, for monitoring the development of secondary events in adult participants diagnosed with TBI (CLIN12.2).
Eligibility Criteria
Inclusion Criteria:
* Presenting to the Emergency Department with a biomechanically plausible mechanism of non-penetrating traumatic brain injury (TBI; direct impact: blow to the head, head against object, object against head; acceleration/deceleration)
* Acute brain CT completed for standard of care
Further Inclusion Criteria (specific for CLIN12.2):
* Admitted to the hospital with radiographic evidence of acute TBI
* Admitted to the intensive care unit at risk for decline related to TBI
Exclusion Criteria:
* Prior neurosurgical intervention within the last 6 months
* Major debilitating neurological disease (such as, but not limited to: stroke, CVA, mild cognitive impairment, Alzheimer's disease, Amyotrophic lateral sclerosis, Parkinson's disease, Huntington's disease, Frontotemporal dementia, tumor, epilepsy, unmanaged seizure disorder), impairing baseline awareness, cognition, or validity of outcomes assessments
* Major debilitating baseline mental health disorders (such as but not limited to schizophrenia or bipolar disorder) that would interfere with follow-up and the validity of outcome assessments
* Significant pre-existing conditions that would interfere with follow-up and outcome assessment (such as, but not limited to: chronic kidney disease, chronic cardiovascular comorbidities, alcohol or substance use disorder)
* History of melanoma
* Primary diagnosis of ischemic or hemorrhagic stroke
* Any spinal Cord Injury (American Spinal Injury Association \[ASIA\] score of A-D)
* Received chemotherapy or radiation currently or within the last year
* Patients on psychiatric hold (e.g., 5150, 5250)
* Current incarceration or in custody
* Known inability to undergo an MRI
* Currently receiving any interventional treatments as a part of an investigational study/trial (drug, device, behavioral, treatment) at the time of enrollment and/or during the course of this study
* Low likelihood of follow-up (e.g. participant or family indicating low interest, residence in another state or country, homelessness or lack of reliable contacts)
* Any condition that, in the opinion of the investigator, could interfere in the proper execution of the study procedures and/or in their future permanence in the study
Source: ClinicalTrials.gov (NCT07455136). StuddyBuddy aggregates publicly available trial information.