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

Detailed 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…

Locations (14)

University Of California Davis, Neurological Surgery
Sacramento, California
University of California San Francisco
San Francisco, California
Goodman Campbell Brain and Spine/Ascension
Carmel, Indiana
Northwell Health - Department Of Neurosurgery
Manhasset, New York
Atrium Health - Carolina Medical Center
Charlotte, North Carolina
University of Cincinnati
Cincinnati, Ohio

Summary

Eligibility

Interventions

Locations (14)