Blood Biomarkers to Improve Management of Mild Traumatic Brain Injury Implementation Study

What this Trial Is About

Researchers are evaluating a new clinical management pathway for patients who come to the emergency department with mild traumatic brain injury (mTBI). This pathway includes using the VIDAS48 TBI blood test, which measures the biomarkers GFAP and UCH-L1 within 12 hours of injury. The study aims to determine if this test can safely and accurately identify patients who do not need a CT scan, and whether its use reduces CT scans and shortens ER stays compared to past patient care without the test. The study compares two groups: a historical group of mild TBI patients managed before the new test was introduced, and a prospective group managed using the biomarker-based pathway. Patients with a Glasgow Coma Scale (GCS) score of 14 or 15 undergo the VIDAS TBI test to decide if a CT scan is needed. Patients with a GCS of 13 or focal neurological deficits receive both biomarker testing and CT scans. The VIDAS test results determine management based on biomarker levels, following established thresholds. Participants will be evaluated during their ER visit, with blood samples collected within 12 hours of injury. Researchers will monitor the diagnostic accuracy of the biomarker test, the proportion of CT scans performed, and ER length of stay. They will also assess adherence to the management protocol. The study plans to enroll around 1000 patients over 6 months, comparing outcomes to a historical control group to assess clinical and operational impacts of the new care pathway.

Implementation of Biomarker-Based Care for mTBI - IMPACTS-BRAINI Study