RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-05-14
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06940232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * 0-17 years of age
  2. * Presentation of non-penetrating trauma
  3. * Blood draw within 24 hours of injury
  4. * For TBI group: head CT or MRI obtained
  1. * Presentation to Children's Nebraska after 24 hours of injury
  2. * 18 years of age or older

Contacts and Locations

Study Contact

Megan McChesney, BSN, RN, CPN
CONTACT
531-375-3835
mmcchesney@unmc.edu

Principal Investigator

Grace Lai, MD, PhD
PRINCIPAL_INVESTIGATOR
University of Nebraska

Study Locations (Sites)

Children's Nebraska
Omaha, Nebraska, 68114
United States

Collaborators and Investigators

Sponsor: University of Nebraska

  • Grace Lai, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Nebraska

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-14
Study Completion Date2027-12

Study Record Updates

Study Start Date2025-05-14
Study Completion Date2027-12

Terms related to this study

Additional Relevant MeSH Terms

  • Pediatric Traumatic Brain Injury