Kids Injury Detection Study Using the i-STAT

The Kids Injury Detection Study using the i-STAT (KIDS-STAT) aims to evaluate whether a rapid blood-based test measuring glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase-L1 (UCH-L1) can accurately identify children with mild traumatic brain injury (mTBI) who do not have acute traumatic findings on head CT. The study will also evaluate test performance across pediatric age groups, assess performance for clinically important TBI and neurosurgically managed lesions, compare biomarker results with PECARN risk categories, and examine whether age, mechanism of injury, and time from injury influence biomarker performance. Clinical outcomes, including return emergency department visits, hospital readmission, delayed neurosurgical intervention, repeat or delayed neuroimaging, and functional status, will also be characterized through 90 days.

The study will enroll children younger than 18 years presenting to the emergency department at Children's Healthcare of Atlanta with suspected non-penetrating mild traumatic brain injury, a Glasgow Coma Scale score of 13-15, and presentation within 24 hours of injury. Participants must have undergone non-contrast head CT as part of their clinical care and have blood collected within 24 hours of injury. Children with penetrating brain injury, presentation outside the 24-hour injury window, or an indeterminate time of injury will not be enrolled.

Participants will undergo a one-time research blood draw during the emergency department visit. Blood will be tested using the i-STAT Alinity TBI system to measure GFAP and UCH-L1, and the biomarker results will be recorded for research analysis. Head CT imaging will be performed as part of standard clinical care, and imaging findings will serve as the reference standard for evaluating biomarker performance. i-STAT results will not be used to guide clinical decision-making or alter patient care.

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