NCT04107662尚未招募不适用
A Prospective, Multi-Center, Non-Randomized Study to Identify Intracranial Hemorrhage by Using an In-Vitro Device, Tbit™ System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 740
- 主要终点
- Cranial CT Intracranial Hemorrhage findings and the binary Tbit™ System (positive/negative)
研究概览
简要总结
A prospective, multi-center, non-randomized, pivotal study to assess the safety and efficacy of the Tbit™ System to aid in patient evaluation, suspected of traumatic brain injury, as adjunct companion test to radiologic standard of care, Cranial Computerized Tomography (CCT).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Prescribed a non-contrast CCT as part of routine emergency care within 24 hours from 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 with a condition precluding entry into the CT scanner
- •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
Cranial CT Intracranial Hemorrhage findings and the binary Tbit™ System (positive/negative)
时间窗: within 12 hours from injury on day 0 of ED presentation
Cranial CT Intracranial Hemorrhage findings (positive/negative) and the binary Tbit™ System results (positive/negative) of each sample.
Tbit™ System sensitivity and specificity
时间窗: within 12 hours from injury on day 0 of ED presentation
Tbit™ System sensitivity and specificity relative to the standard-of-care (SOC)
次要结局
- Safety and adverse event profile(6 months)
- Positive predictive value of the Tbit™ System(within 12 hours from injury on day 0 of ED presentation)
- Overall accuracy of the Tbit™ System(within 12 hours from injury on day 0 of ED presentation)
- Negative predictive value of the Tbit™ System(within 12 hours from injury on day 0 of ED presentation)
研究者
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