Kids Injury Detection Study Using the i-STAT
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-17
SponsorChildren's Healthcare of Atlanta
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children younger than 18 years of age
Presentation to the emergency department with suspected non-penetrating traumatic brain injury resulting from an external force
Glasgow Coma Scale (GCS) score of 13-15 at the time of informed consent
Non-contrast head CT performed within 24 hours of injury as part of clinical care
Disqualifiers
Penetrating brain injury
Presentation more than 24 hours after injury or inability to determine the time of injury
Current participation in a clinical trial involving an investigational therapy for traumatic brain injury
Treatment with an investigational product within the previous 30 days
Trial design
Design model
Single group
Treatments tested in this trial
i-STAT TBI Cartridge with the i-STAT Alinity System
DeviceA 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.
Treatment groups
700 Participants
are divided into 1 treatment groupGroup A: i-STAT TBI Biomarker TestingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Negative Predictive Value of the i-STAT Alinity TBI Test for Traumatic Findings on Head CT
Negative predictive value (NPV) of a negative i-STAT Alinity TBI whole-blood test, defined as GFAP \<65 pg/mL and UCH-L1 \<360 pg/mL, for the absence of acute traumatic findings on head CT in children with mild traumatic brain injury.
Time frame
During the index emergency department visit, within 24 hours of injury2
Sensitivity of the i-STAT Alinity TBI Test for Traumatic Findings on Head CT
Sensitivity of the i-STAT Alinity TBI whole-blood test for detecting acute traumatic findings on head CT in children with mild traumatic brain injury
Time frame
During the index emergency department visit, within 24 hours of injurySecondary outcomes
1
Specificity of the i-STAT Alinity TBI Test for Traumatic Findings on Head CT
Specificity of the i-STAT Alinity TBI whole-blood test for identifying the absence of acute traumatic findings on head CT, evaluated overall and within prespecified age strata (\<5, 5-\<12, and 12-\<18 years).
Time frame
During the index emergency department visit, within 24 hours of injury2
Positive Predictive Value of the i-STAT Alinity TBI Test for Traumatic Findings on Head CT
Positive predictive value (PPV) of the i-STAT Alinity TBI whole-blood test for acute traumatic findings on head CT, evaluated overall and within prespecified age strata (\<5, 5-\<12, and 12-\<18 years).
Time frame
During the index emergency department visit, within 24 hours of injury3
Positive and Negative Likelihood Ratios of the i-STAT Alinity TBI Test
Positive and negative likelihood ratios of the i-STAT Alinity TBI whole-blood test for acute traumatic findings on head CT, evaluated overall and within prespecified age strata (\<5, 5-\<12, and 12-\<18 years).
Time frame
During the index emergency department visit, within 24 hours of injury4
Diagnostic Performance of the i-STAT Alinity TBI Test for Clinically Important Traumatic Brain Injury
Diagnostic performance of the i-STAT Alinity TBI whole-blood test for identifying clinically important traumatic brain injury (ciTBI).
Time frame
During the index emergency department visit and through 90 daysLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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