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NCT06940232 · ClinicalTrials.gov registry record
Validating a Blood Test for the Detection of Traumatic Brain Injury in Children
A clinical trial of Pediatric Traumatic Brain Injury, sponsored by University of Nebraska.
- Recruiting
- Registry status
- 330
- Enrollment target
- 1
- Study location
NCT06940232: Recruiting study of Pediatric Traumatic Brain Injury, sponsored by University of Nebraska.
NCT06940232 is a study of Pediatric Traumatic Brain Injury that is actively recruiting participants, run by University of Nebraska. The registered enrollment target is 330 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06940232, a study of Pediatric Traumatic Brain Injury, is actively recruiting participants, sponsored by University of Nebraska.
- RECRUITING
- Registry status
- 330 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Blood Test for Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase L1 (UCH-L1) Acute Biomarkers
Study Locations (1)
Nebraska
- Children's Nebraska - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 330 participants |
| Start Date | 2025-05-14 |
| Est. Completion | 2027-12 |
What NCT06940232 shows while recruiting
NCT06940232 is an observational study that tracks outcomes without assigning an intervention. The registered 330 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Pediatric Traumatic Brain Injury appearing as the primary indexed condition, and to 1 intervention - of which Blood Test for Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase L1 (UCH-L1) Acute Biomarkers is the first listed.
NCT06940232 reports a single indexed study location in Nebraska.
Frequently Asked Questions
What is clinical trial NCT06940232 about?
NCT06940232 is a clinical study titled "Validating a Blood Test for the Detection of Traumatic Brain Injury in Children". 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 le...
What is the current status of trial NCT06940232?
This trial is currently recruiting. The enrollment target is 330 participants. The study started on 2025-05-14. Estimated completion is 2027-12.
What conditions does trial NCT06940232 study?
This clinical trial studies the following conditions: Pediatric Traumatic Brain Injury.
What interventions are being tested in trial NCT06940232?
The interventions under investigation include: Blood Test for Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase L1 (UCH-L1) Acute Biomarkers (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06940232?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06940232 being conducted?
This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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