RecruitingNCT06940232

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


Sponsor

University of Nebraska

Enrollment

330 participants

Start Date

May 14, 2025

Study Type

OBSERVATIONAL

Conditions

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

Max Age: 17 Years

Inclusion Criteria4

  • -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 Criteria2

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

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Interventions

DIAGNOSTIC_TESTBlood 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

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NCT06940232