Biomarker role in assessing imaging needs for mild cranial trauma (BRAIN-CT): study protocol for a single-center, randomized controlled trial

Introduction: Mild traumatic brain injury (mTBI) accounts for a significant proportion of emergency department (ED) visits, but current diagnostic protocols often lead to overuse of computed tomography (CT) imaging, despite low diagnostic yield. The BRAIN-CT trial evaluates the impact of rapid access to TBI biomarkers on decision-making for cranial imaging in patients with mTBI. Methods and analysis: This randomized controlled trial will enroll 350 adult patients aged 18-85 years presenting with suspected mild head injury (Glasgow Coma Scale 13-15) within 24 h of trauma. Participants will be randomized into two arms: (1) a biomarker-published group where ED providers receive real-time results of the i-STAT® TBI Cartridge test (detecting GFAP and UCH-L1), and (2) a biomarker-blinded group where results are withheld. The primary outcome is the proportion of patients undergoing CT imaging. Secondary outcomes include hospital length of stay, cost, neurological outcomes, and biomarker correlation with imaging findings. Analysis will involve chi-squared testing, logistic regression, and predictive modeling. Clinical trial registration: clinicaltrials.gov, identifier: NCT06932588.