A Point-of-care Electrochemical-based Device for Rapid Detection of Fibrinogen on Type A Aortic Dissection Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The fibrinogen concentration values obtained using the Clauss method and electrochemical method were compared
研究概览
简要总结
This study compares the results of the existing fibrinogen concentration monitoring technology to the Electrochemical-based device, a point-of-care and rapid method,using a small amount of extra blood obtained in Type A Aortic Dissection Surgery.
详细描述
Electrochemical-based device for rapid detection of fibrinogen is a novel POC diagnostic method, which is suitable for operating theatres and emergency rooms.
The novel fibrinogen detection based on Gel electrodes combined with immunobiosensing strategies and use magnitude of current to characterize the fibrinogen concentration , which will be a POC assay of fibrinogen detection for critically ill patients.
This single-center, prospective, observational pilot study will evaluate the analytical performance as well as compared to conventional Clauss laboratory reference method.
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 underwent surgery for acute type A aortic dissection at our hospital, Subject is 18 years, Subject requires routine TEG measurement, Subject use human fibrinogen concentrate during surgery.
排除标准
- •Use Extracorporeal Membrane Oxygenation after surgery, inability to obtain written informed consent
结局指标
主要结局
The fibrinogen concentration values obtained using the Clauss method and electrochemical method were compared
时间窗: 1 day
次要结局
- the time of the two detection methods(1 day)