A Novel Point-to-care Method for Fast Evaluation of Viscoelastic Hemostasis Analysis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Comparison of the novel viscoelastic hemostasis analysis results to TEG results
研究概览
简要总结
This study compares the results of the existing coagulation monitoring technology to the Ultrasound-based viscoelastic hemostasis analysis, a new method, using small amount of extra blood obtained during routine blood draws in surgery patients.
详细描述
Ultrasound-based viscoelastic hemostasis analysis is a novel POC diagnostic method, which is suitable for use in surgical care settings.
The novel viscoelastic hemostasis analysis uses ultrasound guided waves to characterize the dynamic changes in viscoelastic properties of a blood sample during coagulation and clot lysis, which will be the surgical assay for monitoring hemostasis during major surgical procedures in adult patients.
This single-center, prospective, observational pilot study will evaluate the analytical performance as well as compared to standard coagulation tests and comparable measures using conventional viscoelastic testing methods.
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 surgery with general surgery
- •Subject is 18 years or order
- •Subject requires routine TEG measurement
排除标准
- •Subject is unwilling to participate
- •Subject is unable to sign a consent form
- •Subject is unsuitable for blood drawing
- •Subject is unsuitable for this study in the opinion of the anesthesiologist
结局指标
主要结局
Comparison of the novel viscoelastic hemostasis analysis results to TEG results
时间窗: 1 day
Coagulation function assessed by the novel viscoelastic hemostasis analysis and TEG
Comparison of the novel viscoelastic hemostasis analysis results to standard coagulation test results
时间窗: 1 day
Coagulation function assessed by the novel viscoelastic hemostasis analysis and standard coagulation test
次要结局
未报告次要终点