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RECRUITINGOBSERVATIONAL

Validating a Blood Test for the Detection of Traumatic 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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - Presentation to Children's Nebraska after 24 hours of injury - 18 years of age or older Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DIAGNOSTIC_TEST

Blood Test for Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase L1 (UCH-L1) Acute Biomarkers

All groups will have blood drawn per standard of care. Blood samples will be analyzed using Traumatic Brain Injury (TBI) cartridges for iSTAT Alinity device.

Locations (1)

Children's Nebraska
Omaha, Nebraska, United States