Accuracy of CoaguChek XS in Patients With Antiphospholipid Antibody Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- International Normalized Ratio (INR)
研究概览
简要总结
The purpose of this study is to see if the CoaguChek XS is accurate in measuring International Normalized Ratio (INR) in patients with Antiphospholipid Antibody Syndrome (APL) receiving warfarin therapy.
详细描述
Antiphospholipid Antibody Syndrome (APL) is an autoimmune disease that increases ones risk for blood clots. Therefore, these patients receive anticoagulation therapy with warfarin. Point of care devices such as the CoaguChek XS are often used to monitor International Normalized Ratio (INR) in patients on warfarin. However, the antibodies present in patients with APL may lead to false INR results when using the CoaguChek XS. This study will compare the accuracy of the CoaguChek XS in measuring INR in patients with APL by measuring INR by the CoaguChek XS and a standard lab as a reference point. Patients on warfarin for indications other than APL will be measured by both methods as well to serve as a control group.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years of age
- •anticoagulated with warfarin for at least 1 month
- •Diagnosis of antiphospholipid antibody syndrome for intervention arm
排除标准
- •any type of mental disability that would hinder their ability to give informed consent
- •any terminal illness or any other condition that could interfere with study completion, that person will be excluded.
结局指标
主要结局
International Normalized Ratio (INR)
时间窗: Day 1 and Day 60
Compare INR obtained by CoaguChek XS to INR obtained from venous lab draw. Difference of +/- 0.5 considered significant
次要结局
未报告次要终点