Kids Injury Detection Study Using the i-STAT

N/ANot Yet RecruitingNCT07835919

Children's Healthcare of Atlanta700 enrolled

Overview

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.

The Kids Injury Detection Study using the i-STAT (KIDS-STAT) aims to evaluate whether a rapid blood-based test measuring glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase-L1 (UCH-L1) can accurately identify children with mild traumatic brain injury (mTBI) who do not have acute traumatic findings on head CT. The study will also evaluate test performance across pediatric age groups, assess performance for clinically important TBI and neurosurgically managed lesions, compare biomarker results with PECARN risk categories, and examine whether age, mechanism of injury, and time from injury influence biomarker performance. Clinical outcomes, including return emergency department visits, hospital readmission, delayed neurosurgical intervention, repeat or delayed neuroimaging, and functional status, will also be characterized through 90 days. The study will enroll children younger than 18 years presenting to the emergency department at Children's Healthcare of Atlanta with suspected non-penetrating mild traumatic brain injury, a Glasgow Coma Scale score of 13-15, and presentation within 24 hours of injury. Participants must have undergone non-contrast head CT as part of their clinical care and have blood collected within 24 hours of injury. Children with penetrating brain injury, presentation outside the 24-hour injury window, or an indeterminate time of injury will not be enrolled. Participants will undergo a one-time research blood draw during the emergency department visit. Blood will be tested using the i-STAT Alinity TBI system to measure GFAP and UCH-L1, and the biomarker results will be recorded for research analysis. Head CT imaging will be performed as part of standard clinical care, and imaging findings will serve as the reference standard for evaluating biomarker performance. i-STAT results will not be used to guide clinical decision-making or alter patient care.

Eligibility

Sex: ALLMin age: 0 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 * Blood sampling within 24 hours of injury Exclusion Criteria: * 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 * Unsurvivable physical trauma with death expected within 24 hours of enrollment * In the custody of law enforcement or a ward of the state or federal government * Pre-existing neurodegenerative or neurological disease that could interfere with study assessment, including Alzheimer's disease, Parkinson's disease, multiple sclerosis, or brain tumor * Psychiatric disorder that, in the investigator's judgment, could interfere with the participant's or legal representative's ability to understand or comply with study requirements

Outcomes

Primary Outcomes

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 injury

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 injury

Secondary Outcomes

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 injury

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 injury

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 injury

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 days

Diagnostic Performance of the i-STAT Alinity TBI Test for Neurosurgically Managed Lesions

Diagnostic performance of the i-STAT Alinity TBI whole-blood test for identifying traumatic intracranial lesions requiring neurosurgical management.

Time frame: During the index emergency department visit and through 90 days

Association Between i-STAT TBI Test Performance and PECARN Risk Category

Performance of the i-STAT Alinity TBI test will be evaluated in relation to the applicable Pediatric Emergency Care Applied Research Network (PECARN) risk category.

Time frame: During the index emergency department visit

Modeled Potential Reduction in Head CT Use With a Negative i-STAT TBI Test

The potential incremental reduction in head CT use will be estimated under a strategy in which a negative i-STAT TBI test is used to defer imaging.

Time frame: During the index emergency department visit

Diagnostic Performance of Individual GFAP and UCH-L1 Biomarkers

Diagnostic accuracy of GFAP alone and UCH-L1 alone for traumatic findings on head CT. Analyses will also assess the influence of age, mechanism of injury, and time from injury on individual biomarker performance.

Time frame: During the index emergency department visit, within 24 hours of injury

Age-Specific Thresholds for a Negative i-STAT TBI Test

Evaluation of whether alternative biomarker thresholds for a negative test within each age group can improve positive predictive value without compromising negative predictive value.

Time frame: During the index emergency department visit, within 24 hours of injury

Comparison of Biomarker Measurements Between Tasso+ and Standard Phlebotomy Samples

Biomarker yield, assay validity, quantitative concordance, invalid-result rate, and diagnostic accuracy will be compared between Tasso+ and standard phlebotomy blood samples.

Time frame: During the index emergency department visit

Clinical Outcomes Following Pediatric Mild Traumatic Brain Injury

Clinical outcomes will include return emergency department visits, hospital readmission, delayed neurosurgical intervention, repeat or delayed neuroimaging, and functional status.

Time frame: Up to 90 days after the index emergency department visit

Kids Injury Detection Study Using the i-STAT

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts