Recruiting

Observational Study

Sponsor:

University of Nebraska

Code:

NCT06940232

Conditions

Pediatric Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Interventions

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

Study Details

Brief 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.

Conditions

Pediatric Traumatic Brain Injury

Study ID

NCT06940232

Start date

May 14, 2025

Status verified date

Jun, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

330 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Comparison of Serum Glial Fibrillary Acidic Protein Levels, an Acute Biomarker, Among Children With Traumatic Brain Injury and Control Groups [ Time Frame: Within 24 hours of injury ]
  • Comparison of Ubiquitin C-terminal Hydrolase L1 Levels, an Acute Biomarker, Among Children With Traumatic Brain Injury and Control Groups [ Time Frame: Within 24 hours of injury ]
  • Comparison of Serum Glial Fibrillary Acidic Protein Levels, an Acute Biomarker, Between Children With Traumatic Brain Injury With Normal and Abnormal Head Computed Tomography Scan [ Time Frame: Within 24 hours of injury ]
  • Comparison of Ubiquitin C-terminal Hydrolase L1 Levels, an Acute Biomarker, in Children With Traumatic Brain Injury With Normal and Abnormal Head Computed Tomography Scan [ Time Frame: Within 24 hours of injury ]
  • Comparison of Serum Glial Fibrillary Acidic Protein Levels, an Acute Biomarker, and Clinical Outcomes in Children With Traumatic Brain Injury Using Post-Concussion Symptom Inventory [ Time Frame: 3 months and 6 months after traumatic brain injury ]
  • Comparison of Ubiquitin C-terminal Hydrolase L1 Levels, an Acute Biomarker, and Clinical Outcomes in Children With Traumatic Brain Injury Using Post-Concussion Symptom Inventory [ Time Frame: 3 months and 6 months after traumatic brain injury ]
  • Comparison of Serum Glial Fibrillary Acidic Protein Levels, an Acute Biomarker, and Clinical Outcomes in Children With Traumatic Brain Injury Using Pediatric Cerebral Performance Category Scale [ Time Frame: 3 months and 6 months after traumatic brain injury ]
  • Comparison of Ubiquitin C-terminal Hydrolase L1 Levels, an Acute Biomarker, and Clinical Outcomes in Children With Traumatic Brain Injury Using Pediatric Cerebral Performance Category Scale [ Time Frame: 3 months and 6 months after traumatic brain injury ]

Central Contacts and Locations

Central contacts

Megan McChesney, BSN, RN, CPN

531-375-3835mmcchesney@unmc.edu

Locations

Children's Nebraska

Recruiting

Omaha, Nebraska, United States, 68114

Contacts

Megan McChesney, BSN, RN, CPN

531-375-3835mmcchesney@unmc.edu

Principal Investigator:

Grace Lai, MD, PhD

More Information

Sponsor

University of Nebraska

Last update posted

Aug 14, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Nebraska on 2026-08-14.