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Recruiting NCT06940232

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

Conditions: Pediatric Traumatic Brain Injury

Sex: All
Ages: N/A – 17 Years
Healthy volunteers: No
Enrollment: 330
Sponsor: University of Nebraska

Location: Children's Nebraska Omaha Nebraska

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06940232). StuddyBuddy aggregates publicly available trial information.