Actively Recruiting

Age: 0 - 17Years
All Genders
NCT06940232

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

Led by University of Nebraska · Updated on 2025-07-30

330

Participants Needed

1

Research Sites

133 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 0 - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participant is between 0 and 17 years old
  • Presented with non-penetrating trauma
  • Blood sample was drawn within 24 hours of injury
  • Head CT or MRI scan was obtained for TBI group
Not Eligible

You will not qualify if you...

  • Presentation to the hospital more than 24 hours after injury
  • Participant is 18 years old or older

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Children's Nebraska

Omaha, Nebraska, United States, 68114

Actively Recruiting

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Research Team

M

Megan McChesney, BSN, RN, CPN

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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