Multicenter Study to Develop a Blood Test for Diagnosing and Predicting Outcomes in Adults with Traumatic Brain Injury and Monitoring Secondary Events

What this Trial Is About

Researchers are conducting a study to develop a blood-based biomarker test that helps diagnose traumatic brain injury TBI in adults and predict outcomes after injury. The study also aims to monitor the development of secondary events in hospitalized adults diagnosed with TBI. This research is designed to improve diagnostic and prognostic tools for TBI using blood tests compared with clinical imaging and assessments. Participants will provide blood samples which will be analyzed to identify biomarker panels. The study includes two groups one with adults suspected of TBI presenting at the emergency department with a recent injury and a completed brain CT scan the other with hospitalized patients who have confirmed acute TBI and are at risk of neurological decline. The blood samples are collected as part of standard care in the acute phase up to two weeks post-injury. During the study, participants undergo clinical evaluations, imaging, and blood sample collection to assess TBI diagnosis, neurological worsening, and outcome scales at days 14, 28, and 90. Researchers will compare biomarker test results with imaging, clinical findings, and Glasgow Outcome Scale-Extended scores to evaluate test accuracy for diagnosis and prognosis. Monitoring will focus on the occurrence of secondary brain injury events in hospitalized patients. The study duration extends to follow-up assessments up to 90 days after 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