NCT06940232 Validating a Blood Test for the Detection of Traumatic Brain Injury in Children
| NCT ID | NCT06940232 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Nebraska |
| Condition | Pediatric Traumatic Brain Injury |
| Study Type | OBSERVATIONAL |
| Enrollment | 330 participants |
| Start Date | 2025-05-14 |
| Primary Completion | 2027-05 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 0-17 years of age * Presentation of non-penetrating trauma * Blood draw within 24 hours of injury * For TBI group: head CT or MRI obtained Exclusion Criteria: * Presentation to Children's Nebraska after 24 hours of injury * 18 years of age or older