Point-of-care blood test to detect brain injury in children

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

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
• Enrollment: 330 (estimated)
• Ages: N/A to 17 Years
• Sex: All
• Sponsor: University of Nebraska (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Omaha, Nebraska)
• Trial ID: NCT06940232 on ClinicalTrials.gov

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.

Who should consider this trial

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).

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.

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 performed: 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.

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

Where this trial is running

Omaha, Nebraska

• 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

Conditions Pediatric Traumatic Brain Injury