Validating a Blood Test for the Detection of Traumatic Brain Injury in Children

The primary objective of this study is to establish if Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase L1 (UCH-L1) are predictive of computed tomography (CT) findings in pediatric traumatic brain injuries (TBI). The participant population is pediatric patients, ages 0 to less than 18 years old with a possible TBI or trauma-related injury who have blood drawn per standard of care in the emergency department. Blood samples will be analyzed using the i-STAT TBI cartridge (Abbott Laboratories, Abbott Park, IL, USA) by the Emergency Department charge nurse within one hour of collection of the blood sample. Clinical outcomes will be assessed via telephone interview with a parent at 3 and 6 months for all surviving TBI patients.

NCT Number	NCT06940232
Lead Sponsor	University of Nebraska
Conditions	Pediatric Traumatic Brain Injury
Enrollment	330 participants
Start Date	2025-05-14
Primary Completion	2027-05 (estimated)
Study Completion	2027-12 (estimated)
Updated on ClinicalTrials.gov	2026-08-14