RecruitingTraumatic Brain Injury

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

Eligible age

18+ yrs

Accepts

All genders

Locations

11 states

Healthy volunteers

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About this study

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).

Sponsor: Hoffmann-La Roche

You may qualify if…

✓ 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

You may not qualify if…

✕ 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