NCT06940232 Validating a Blood Test for the Detection of Traumatic Brain Injury in Children
| NCT ID | NCT06940232 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Nebraska |
| Condition | Pediatric Traumatic Brain Injury |
| Study Type | OBSERVATIONAL |
| Enrollment | 330 participants |
| Start Date | 2025-05-14 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 330 participants in total. It began in 2025-05-14 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Grace Lai, MD, PhD
PRINCIPAL INVESTIGATOR
University of Nebraska
Frequently Asked Questions
Who can join the NCT06940232 clinical trial?
This trial is open to participants of all sexes, up to 17 Years, studying Pediatric Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06940232 currently recruiting?
Yes, NCT06940232 is actively recruiting participants. Contact the research team at mmcchesney@unmc.edu for enrollment information.
Where is the NCT06940232 trial being conducted?
This trial is being conducted at Omaha, United States.
Who is sponsoring the NCT06940232 clinical trial?
NCT06940232 is sponsored by University of Nebraska. The principal investigator is Grace Lai, MD, PhD at University of Nebraska. The trial plans to enroll 330 participants.