Kids Injury Detection Study Using the i-STAT

KIDS-STAT is a prospective study evaluating whether a rapid blood test measuring the brain injury biomarkers GFAP and UCH-L1 using the i-STAT Alinity system can help identify children with mild traumatic brain injury who do not have acute traumatic findings on head CT. The study will include children younger than 18 years who present within 24 hours of a suspected mild traumatic brain injury. Blood will be collected during the emergency department visit and tested using the i-STAT TBI cartridge. The test results will be used for research purposes only and will not be used to make clinical care decisions. The primary objective is to determine how reliably a negative i-STAT TBI result identifies children without traumatic findings on head CT. Secondary analyses will evaluate test performance across age groups and in relation to clinical characteristics and outcomes.

Inclusion Criteria: * Children younger than 18 years of age * Presentation to the emergency department with suspected non-penetrating traumatic brain injury resulting from an external force * Glasgow Coma Scale (GCS) score of 13-15 at the time of informed consent * Non-contrast head CT performed within 24 hours of injury as part of clinical care * Blood sampling within 24 hours of injury Exclusion Criteria: * Penetrating brain injury * Presentation more than 24 hours after injury or inability to determine the time of injury * Current participation in a clinical trial involving an investigational therapy for traumatic brain injury * Treatment with an investigational product within the previous 30 days * Unsurvivable physical trauma with death expected within 24 hours of enrollment * In the custody of law enforcement or a ward of the state or federal government * Pre-existing neurodegenerative or neurological disease that could interfere with study assessment, including Alzheimer's disease, Parkinson's disease, multiple sclerosis, or brain tumor * Psychiatric disorder that, in the investigator's judgment, could interfere with the participant's or legal representative's ability to understand or comply with study requirements