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NOT YET RECRUITING
NCT07835919
NA

Kids Injury Detection Study Using the i-STAT

Sponsor: Children's Healthcare of Atlanta

View on ClinicalTrials.gov

Summary

KIDS-STAT is a prospective study evaluating whether a rapid blood test measuring the brain injury biomarkers GFAP and UCH-L1 using the i-STAT Alinity system can help identify children with mild traumatic brain injury who do not have acute traumatic findings on head CT. The study will include children younger than 18 years who present within 24 hours of a suspected mild traumatic brain injury. Blood will be collected during the emergency department visit and tested using the i-STAT TBI cartridge. The test results will be used for research purposes only and will not be used to make clinical care decisions. The primary objective is to determine how reliably a negative i-STAT TBI result identifies children without traumatic findings on head CT. Secondary analyses will evaluate test performance across age groups and in relation to clinical characteristics and outcomes.

Official title: Kids Injury Detection Study (KIDS-STAT) Using the i-STAT: Point of Care TBI Biomarker Testing

Key Details

Gender

All

Age Range

0 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

700

Start Date

2026-10

Completion Date

2032-01

Last Updated

2026-09-23

Healthy Volunteers

No

Interventions

DEVICE

i-STAT TBI Cartridge with the i-STAT Alinity System

A point-of-care blood test measuring glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase-L1 (UCH-L1). A blood sample will be analyzed using the i-STAT Alinity system, and biomarker values will be recorded for research analysis.