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

NCT ID: NCT06940232

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 330 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-14
• Study Completion Date: 2027-12-31

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.

Detailed Description

The Centers for Disease Control and Prevention (CDC) estimates 3,000 deaths annually in children and youth from traumatic brain injury (TBI), 29,000 hospitalizations, and 400,000 emergency room visits . A prospective study lead by the Pediatric Emergency Care Applied Research Network (PECARN) reported that 35.5% of 40,000 children who presented with a mild TBI (Glasgow Coma Scale, GCS, 14-15) had a head computed tomography (CT) scan, of which only 0.9% were clinically significant, and 0.1% required neurosurgical intervention, which led to the development of an algorithm for the need for CT imaging in pediatric mild TBI. However, a large scale study of the National Hospital Ambulatory Care Medical Survey database from 2008-2015 did not show a decrease in children undergoing CT imaging. Thus, there is still a need for a more definitive means to predict intracranial injury to avoid radiation exposure in children.

In 2018, the US Food and Drug Administration (FDA) approved the first blood test to assess mild TBI for adults with suspected brain injury. A portable point-of-care platform was made available that could detect concentrations of serum and plasma concentrations of Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase L1 (UCH-L1) in 15 minutes to predict evidence of intra-cranial hemorrhage on CT. Although not yet FDA approved in children, some studies showed that GFAP and UCH-L1 were able to distinguish children with concussive symptoms from body trauma controls, while others showed significantly higher levels of GFAP, but not UCH-L1. These studies did not test the hypothesis of serum biomarkers for prediction of evidence of intracranial injury on cranial imaging. Thus, further studies are needed to determine if these biomarkers can be used in the pediatric population to predict degree of intracranial injury.

Investigators propose a prospective case-control study that is comprised of three groups: participants with mild TBI, Glasgow Coma Scale (GCS) 13-15, participants with moderate to severe TBI (GCS <13), and a control group that includes other trauma participants with no history of head injury. Patients under the age of 18 (0-17) who present to the emergency room in the setting of non-penetrating trauma will be screened. All patients with blood obtained for clinical purposes will be included in the study. Written consent for prospective follow-up will be obtained from parents prior to discharge from the hospital. Participant demographic and clinical information will be abstracted from chart review.

The aims of the study are to determine GFAP and UCH-L1 levels within 24 hours of head injury in children with moderate/severe TBI (GCS 3-12) compared to those with mild TBI (GCS 13-15) and trauma patients without clinical concern for TBI, to determine if serum GFAP and UCH-L1 levels are higher in children with TBI and an abnormal head CT scan compared to those with TBI and normal head CT scan, and to determine if higher serum GFAP and UCH-L1 are predictive of worse clinical outcomes 3 and 6 months after TBI via the Post-Concussion Symptom Inventory and the Pediatric Cerebral Performance Category Scale surveys.

Conditions

Pediatric Traumatic Brain Injury

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

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

Intervention Type: DIAGNOSTIC_TEST

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.

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).

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

Intervention Type: DIAGNOSTIC_TEST

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.

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.

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

Intervention Type: DIAGNOSTIC_TEST

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.

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Grace Lai, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

Children's Nebraska

Omaha, Nebraska, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Megan McChesney, BSN, RN, CPN

Role: CONTACT

mmcchesney@unmc.edu

531-375-3835

Facility Contacts

Megan McChesney, BSN, RN, CPN

Role: primary

mmcchesney@unmc.edu

531-375-3835

Other Identifiers

0423-24-EP

Identifier Type: -

Identifier Source: org_study_id