NCT01037270已完成不适用
Evaluation of the Accuracy and Precision of the INRatio® Prothrombin Time (PT) Monitoring System With New INRatio Test Strip Designed for Low Sample Volume and Heparin Insensitivity
Abbott RDx Cardiometabolic4 个研究点 分布在 1 个国家目标入组 271 人开始时间: 2009年8月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 271
- 试验地点
- 4
- 主要终点
- Analytical accuracy and precision of the INRatio Prothrombin Time (PT) Monitoring System.
研究概览
简要总结
This is a multi-center study designed to evaluate the accuracy and precision of the INRatio® Prothrombin Time (PT) Monitoring System, utilizing the INRatio test strip newly designed for low sample volume and heparin insensitivity, when used by trained medical professionals for the quantitative determination of PT and International Normalized Ratio (INR) in fingerstick and venous whole blood from subjects on oral anticoagulation therapy (OAT). These results will be compared to those PT/INR results obtained on plasma from the same subjects as analyzed at a central laboratory with the Sysmex CA-560 System.
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
- 是
入选标准
- •Adults (18 years of age or older);
- •Willing and able to provide written informed consent and comply with study procedures;
- •Subjects on oral anticoagulation therapy. This inclusion criterion is waived for the 20 normal healthy volunteers who must NOT be on warfarin or any other anticoagulant drug.
排除标准
- •Hematocrit less than 25 or greater than 55%;
- •Lupus or antiphospholipid syndrome (APS)
- •Vulnerable populations deemed inappropriate for study by the site's principal investigator.
- •Already participated in this study.
结局指标
主要结局
Analytical accuracy and precision of the INRatio Prothrombin Time (PT) Monitoring System.
时间窗: 3-6 months
次要结局
未报告次要终点
研究者
研究点 (4)
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