A Multicenter Prospective Study to Develop a Blood-based Biomarker Test for Aiding the Diagnosis/Prognosis of Traumatic Brain Injury in Adult Subjects (CLIN12.1) and for Monitoring the Development of Secondary Events in Patients Diagnosed With Traumatic Brain Injury (CLIN12.2)
Hoffmann-La Roche
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- ProcedureBlood sample collection
Blood samples from each enrolled participant in CLIN12.1 and/or CLIN12.2 will be collected.
Locations (12)
- University Of California Davis, Neurological SurgerySacramento, California
- University of California San FranciscoSan Francisco, California
- Goodman Campbell Brain and Spine/AscensionCarmel, Indiana
- Atrium Health - Carolina Medical CenterCharlotte, North Carolina
- University of CincinnatiCincinnati, Ohio
- University of Pennsylvania Medical CenterPhiladelphia, Pennsylvania