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Kids Injury Detection Study Using the i-STAT

Study acronym: KIDS-STAT
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07835919
Lead Sponsor Children's Healthcare of Atlanta
Collaborators: Abbott, Emory University
Conditions
(from sponsor)		 Mild Traumatic Brain Injury, Pediatric Traumatic Brain Injury, Head Trauma
Related terms Brain Concussion, Craniocerebral Trauma
Enrollment 700 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov