NCT04893837已完成不适用
Non-Invasive Monitoring of Traumatic Brain Injury Progression Using the Infrascanner (MOBI-1)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 399
- 试验地点
- 2
- 主要终点
- Diagnostic performance of the infrascanner
研究概览
简要总结
MOBI-1 is a multicenter clinical trial that will evaluate the use of the Infrascanner for the monitoring of traumatic intracranial hematomas.
详细描述
MOBI-1 is a single-arm, multi-center derivation / validation study that will evaluate the use of the Infrascanner for monitoring traumatic intracranial hematomas. All patients will receive standard care plus hourly infrascanner assessments. This study will test the hypotheses that:
- The Infrascanner has sufficient diagnostic performance to detect the expansion of intracranial hematomas
- Patients who have expanding intracranial hematomas will be identified faster when monitored with hourly infrascanner assessments compared to standard care alone
- Clinical / research staff will be able to attain all data points and relay the assessments to the medical team.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 15 or older
- •Admission CT Scan shows intracranial hemorrhage
- •Glasgow Coma Scale less than 15
- •Neurosurgery service determines initial care is nonoperative
- •Admitted for observation for TBI, to either step-down unit or intensive care unit
排除标准
- •Inability to provide informed consent or lack of a legally authorized representative (LAR)
- •Admitted and observed for >2 hours prior to screening (i.e., has already received second neurological check)
- •Other injuries deemed non-survivable
- •Diagnosed with hemorrhagic shock or receives a large volume transfusion (>3 units of any blood product within any 1 hour)
- •Planned surgical interventions/ procedures during study period (before the second CT scan)
- •Known prisoner
结局指标
主要结局
Diagnostic performance of the infrascanner
时间窗: Month 24
Number of participants whose Infrascan results were accurate
次要结局
- Time to detection of an enlarging hematoma(0-12 hours)
研究者
Jan O. Jansen
Professor and Director, UAB Center for Injury Science
University of Alabama at Birmingham
研究点 (2)
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