A Prospective, Multi-Center, Blood Collection Study to Evaluate TbitTM System Precision and Correlation Between Different Blood Samples Measured With TbitTM System
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 81
- 主要终点
- Measurement Repeatability
研究概览
简要总结
The Tbit™ System will detect S100B and GFAP concentrations with the blood specimen to produce and compare repeated measures from 3 blood samples from 3 fingersticks from one subject and one 1 venous whole blood sample will be collected from the same subject, on 3 different Tbit™ System by 3 different operators.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age
- •Presents to the Emergency Department with suspected traumatic brain injury
- •Blood sample collected for Tbit™ System within 12 hours of injury
- •Willing and able to provide informed consent or obtain consent from legal authorized representative (LAR)
排除标准
- •Suspect of ischemic or hemorrhagic stroke with subsequent incidental trauma based on ED examination
- •Subject suspect of need of craniotomy for the acute trauma for this event
- •External signs compatible with a depressed skull fracture based on ED exam
- •Subject requiring administration of blood transfusion after injury and prior to study blood draw
- •Subject for whom timing of injury is unable to be estimated within 1 hour of certainty
- •Subject who had neurodegenerative disease or other neurological disorder including dementia, Parkinson's disease, multiple sclerosis, seizures, brain tumors, stroke or TIA within the last 30 days, or history of neurosurgery
- •Known or suspected to be pregnant
- •Prisoner or under incarceration
- •Participating in another clinical research study prior to this study completion
结局指标
主要结局
Measurement Repeatability
时间窗: within 12 hours from injury for Tbit and within 30 min from the sample drawn
1\. Evaluate the repeatability of measurement of S100B and GFAP concentrations in capillary blood using the Tbit™ System at different clinical sites and between-instrument and between-operator components of variance in the intended use environment.
Compare Measurements
时间窗: within 12 hours from injury
2\. Compare concentrations of S100B and GFAP measured using Tbit™ System in specimens obtained from a fingerstick blood, venous whole blood, serum and plasma in the intended use environment.
次要结局
未报告次要终点