A Novel Viscoelastic Test Based on Ultrasonic Guided Wave for Identifying Hyperfibrinolysis Rapidly
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Comparison of the novel viscoelastic hemostasis analysis results to TEG-LY30
研究概览
简要总结
This study compares the results of the existing fibrinolysis 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 operating theatres and emergency rooms.
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 an assay of hyperfibrinolysis for critically ill patients.
This single-center, prospective, observational pilot study will evaluate the analytical performance as well as compared to conventional viscoelastic testing methods.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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 with coagulation and fibrinolysis exceeding normal values based on laboratory tests (including prothrombin time, international normalized ratio, activated partial thromboplastin time, plasma fibrinogen concentration, D-dimer, platelet count, hemoglobin concentration, and hematocrit) Subject with any abnormal parameters detected by TEG Subject with a history of bleeding and thrombosis Subject who has taken any medications that may affect coagulation, platelet aggregation, or fibrinolysis within the past 10 days (including non-steroidal anti-inflammatory drugs and aspirin) Residual blood volume <1ml
- •Inclusion Criteria:
- •Subject is scheduled for surgery with general surgery Subject is 18 years or order Subject Subjects with detected hyperfibrinolysis (LY30>8%) or non-hyperfibrinolysis(LY30≤8%) based on TEG.
- •Exclusion Criteria:
- •Residual blood volume <1ml
结局指标
主要结局
Comparison of the novel viscoelastic hemostasis analysis results to TEG-LY30
时间窗: 1 day
Fibrinolysis capacity assessed by the novel viscoelastic hemostasis analysis and TEG-LY30
次要结局
未报告次要终点