Point-of-care blood test to detect brain injury in children
Official title: Ubiquitin C-terminal Hydrolase L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP) as Acute Biomarkers for Prediction of Traumatic Brain Injury (TBI) in Children
Run by University of Nebraska · NCT06940232 · Data updated 2026-11-12
This project will test whether a quick blood test that measures GFAP and UCH-L1 can identify brain injuries in children who come to the emergency department after head trauma.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 17 Years |
| Sex | All |
| Enrollment | 330 (estimated) |
| Sponsor | University of Nebraska Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Omaha, Nebraska) |
| Status | Recruiting |
| Started | May 14, 2025 |
| Main results expected | May 2027 |
| Study ends | December 2027 |
| Registry record updated | August 14, 2026 |
| Trial ID | NCT06940232 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 0–17 who present to the emergency department within 24 hours of non-penetrating head trauma and have blood drawn as part of standard care (with head CT or MRI obtained for the TBI comparison group).
✕Probably not a fit
Children who present more than 24 hours after injury, have penetrating injuries, are 18 or older, or do not have blood drawn per standard care or imaging are not eligible and are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective observational study enrolling children 0–17 years old who present with non-penetrating head trauma and have blood drawn as part of emergency care. Blood samples collected within 24 hours of injury are analyzed at the bedside using the i-STAT TBI cartridge for GFAP and UCH-L1 concentrations. Results will be compared to head CT or MRI findings in the TBI group to see how well the biomarkers predict intracranial injury. Clinical outcomes for surviving TBI patients will be collected by telephone interview with a parent at 3 and 6 months.
Why it matters
Potential benefit: If successful, the test could help clinicians rule in or rule out intracranial injury more quickly and reduce unnecessary CT scans and radiation exposure for children.
How similar studies have gone: An adult blood test measuring GFAP and UCH-L1 received FDA clearance in 2018 and smaller pediatric studies have shown promise, but large-scale pediatric validation remains limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Children's Nebraska
Omaha, Nebraska, United States Recruiting
Study contacts
- Principal investigator: Grace Lai, MD, PhD — University of Nebraska
- Study coordinator: Megan McChesney, BSN, RN, CPN
- Email: mmcchesney@unmc.edu
- Phone: 531-375-3835
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.