Kids Injury Detection Study (KIDS-STAT) Using the i-STAT: Point of Care TBI Biomarker Testing
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 700
- 主要终点
- Negative Predictive Value of the i-STAT Alinity TBI Test for Traumatic Findings on Head CT
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
i-STAT TBI Biomarker Testing
Participants will undergo blood-based biomarker testing using the i-STAT TBI Cartridge with the i-STAT Alinity System. GFAP and UCH-L1 values will be collected for research purposes and compared with head CT findings obtained as part of standard clinical care. Biomarker results will not be used to guide clinical decision-making.
干预措施: i-STAT TBI Cartridge with the i-STAT Alinity System (Device)
结局指标
主要结局
Negative Predictive Value of the i-STAT Alinity TBI Test for Traumatic Findings on Head CT
时间窗: During the index emergency department visit, within 24 hours of injury
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.
Sensitivity of the i-STAT Alinity TBI Test for Traumatic Findings on Head CT
时间窗: During the index emergency department visit, within 24 hours of injury
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
次要结局
- Specificity of the i-STAT Alinity TBI Test for Traumatic Findings on Head CT(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(During the index emergency department visit, within 24 hours of injury)
- Positive and Negative Likelihood Ratios of the i-STAT Alinity TBI Test(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(During the index emergency department visit and through 90 days)
- Diagnostic Performance of the i-STAT Alinity TBI Test for Neurosurgically Managed Lesions(During the index emergency department visit and through 90 days)
- Association Between i-STAT TBI Test Performance and PECARN Risk Category(During the index emergency department visit)
- Modeled Potential Reduction in Head CT Use With a Negative i-STAT TBI Test(During the index emergency department visit)
- Diagnostic Performance of Individual GFAP and UCH-L1 Biomarkers(During the index emergency department visit, within 24 hours of injury)
- Age-Specific Thresholds for a Negative i-STAT TBI Test(During the index emergency department visit, within 24 hours of injury)
- Comparison of Biomarker Measurements Between Tasso+ and Standard Phlebotomy Samples(During the index emergency department visit)
- Clinical Outcomes Following Pediatric Mild Traumatic Brain Injury(Up to 90 days after the index emergency department visit)
研究者
Andrew Reisner, MD
Medical Director, Neuro Trauma and Concussion
Children's Healthcare of Atlanta