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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Maximum Age: 17
Healthy Volunteers: f
View:

• 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

Locations
United States
Nebraska
Children's Nebraska
RECRUITING
Omaha
Contact Information
Primary
Megan McChesney, BSN, RN, CPN
mmcchesney@unmc.edu
531-375-3835
Time Frame
Start Date: 2025-05-14
Estimated Completion Date: 2027-12
Participants
Target number of participants: 330
Treatments
Group 1 - Traumatic Brain Injury With Positive Head Computed Tomography Findings
Group 1 will be 110 participants who had a traumatic brain injury (TBI) with positive head computed tomography (HCT).
Group 2 - Traumatic Brain Injury With Negative Head Computed Tomography Findings
Group 2 will be 110 participants with a known traumatic brain injury (TBI), but a negative head computed tomography (HCT).
Group 3 - All Other Trauma Participants With No History of Head Injury
Group 3 will be 110 participants being treated for a traumatic injury with no history of head injury.
Related Therapeutic Areas
Sponsors
Leads: University of Nebraska

This content was sourced from clinicaltrials.gov