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

Recruiting now

Conditions studied: Pediatric Traumatic Brain Injury

In brief

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.

Key facts

Study ID

NCT06940232

Run by

University of Nebraska

People needed

330

Starts

2025-05-14

Expected to finish

2027-12-01

Last updated by the study team

2025-07-30

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Presentation to Children's Nebraska after 24 hours of injury
• 18 years of age or older

Where it is running

• Children's Nebraska — Omaha, Nebraska, United States (enrolling)

Full record on ClinicalTrials.gov

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