NCT06940232 · University of Nebraska
Validating a Blood Test for the Detection of Traumatic Brain Injury in Children
What this study 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).
View original scientific 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.
Interventions
DIAGNOSTIC_TEST
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 measures
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
Serum Glial Fibrillary Acidic Protein (GFAP) levels measured with a i-STAT TBI cartridge within 24 hours of head injury will be compared in children with moderate/severe traumatic brain injury (TBI), Glasgow Coma Scale (GCS) 3-12, mild TBI (GCS 13-15) and trauma participants without clinical concern for TBI.
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
Serum Ubiquitin C-terminal Hydrolase L1 (UCH-L1) levels measured with a i-STAT TBI cartridge within 24 hours of head injury will be compared in children with moderate/severe traumatic brain injury (TBI), Glasgow Coma Scale (GCS) 3-12, mild TBI (GCS 13-15) and trauma participants without clinical concern for TBI.
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
Serum Glial Fibrillary Acidic Protein (GFAP) measured with a i-STAT TBI cartridge within 24 hours of traumatic brain injury (TBI) and a normal head computed tomography (CT) scan will be compared to levels in children with TBI and an abnormal head computed tomography (CT) scan.
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
Serum Ubiquitin C-terminal Hydrolase L1 (UCH-L1) levels in children with traumatic brain injury (TBI) and a normal head computed tomography (CT) scan will be compared to levels in children with (TBI) and an abnormal head computed tomography (CT) scan.
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
Serum Glial Fibrillary Acidic Protein (GFAP) levels in children with traumatic brain injury (TBI) will be compared to clinical outcomes using the Post-Concussion Symptom Inventory. The Inventory rates 23 symptoms from 0 (none) to 6 (severe).
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
Serum Ubiquitin C-terminal Hydrolase L1 (UCH-L1) levels in children with traumatic brain injury (TBI) will be compared to clinical outcomes using the Post-Concussion Symptom Inventory. The Inventory rates 23 symptoms from 0 (none) to 6 (severe).
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
Serum Glial Fibrillary Acidic Protein (GFAP) levels in children with traumatic brain injury (TBI) will be compared to clinical outcomes using the Pediatric Cerebral Performance Category Scale. This scale rates 5 functional categories from 1 (normal) to 6 (vegetative state).
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
Serum Ubiquitin C-terminal Hydrolase L1 (UCH-L1) levels in children with traumatic brain injury (TBI) will be compared to clinical outcomes using the Pediatric Cerebral Performance Category Scale. This scale rates 5 functional categories from 1 (normal) to 6 (vegetative state).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Omaha, Nebraska
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 30, 2025 · Source of record for eligibility and locations