HemoSonics-UVA Spinal Surgery Clinical Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- assay inter-instrument variability
研究概览
简要总结
This study compares the results of current standard coagulation measurement devices to the Quantra System, a new device, using small amount of extra blood obtained during routine blood draws in neurosurgery patients.
详细描述
HemoSonics is developing a novel POC diagnostic device, the Quantra System, to perform whole blood coagulation analysis and which is suitable for use in surgical and intensive care settings. The Quantra System employs a patented technology named sonorheometry, which was invented at the University of Virginia.
Sonorheometry uses ultrasound pulses to characterize the dynamic changes in viscoelastic properties of a blood sample during coagulation and clot lysis. The initial assay performed on the Quantra System will be the surgical assay for monitoring hemostasis during major surgical procedures in adult patients.
A clinical study will be conducted to evaluate the analytical performance as well as compared to existing coagulation monitoring technology
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
- •• Subject is scheduled for major deformity correction spine surgery
- •Subject is older than 18 years
- •Subject is willing to participate and he/she has signed a consent form
排除标准
- •• Subject is unable to provide written informed consent
- •Subject is incarcerated at the time of the study
- •Subject is affected by any condition that, in the opinion of the surgical team, may pose additional risks
- •Subjects with renal disease (defined as serum creatinine greater than 1.5 mg/dl)
- •Subjects with history of active liver disease
- •Subjects affected by Factor V Leiden mutation
- •Subjects affected by von Willebrand disease
- •Subjects with an history of thrombotic disease (more than one DVT)
结局指标
主要结局
assay inter-instrument variability
时间窗: 1 day
Demonstrate assay inter-instrument variability below 15%
Establish normal ranges
时间窗: 1 day
Establish normal ranges
次要结局
未报告次要终点
研究者
Bhiken I. Naik, MD
UVA Anesthesiology Faculty
University of Virginia