Point of Care Testing INR in Antiphospholipid Syndrome (POCTAS)
Explaining the Differences Between Capillary INR and Plasma INR in Patients With Antiphospholipid Syndrome
Antiphospholipid syndrome (APS) is an autoimmune and prothrombotic disorder that can affect up to 10% of young people experiencing a thrombotic event. Its treatment relies on long-term anticoagulation with vitamin K antagonists (VKAs). Direct oral anticoagulants, which are simpler to use because they do not require regular blood monitoring, are contraindicated because they are associated with an increased risk of thrombotic recurrence in some patients with APS.
Patients with APS receive VKAs and must regularly have their Index Normalized Ratio (INR) measured via a cumbersome venous blood draw. Capillary INR measurement systems are already used in certain situations, such as in patients with mechanical heart valves. The use of these systems improves the quality of life of these patients and, above all, the stability of VKA therapy, thus preventing potentially serious hemorrhagic complications or thrombotic recurrences.
In antiphospholipid syndrome (APS), these systems are discouraged due to perceived differences between capillary and venous INR (the reference method). However, among the few studies on the subject, none demonstrated significant discrepancies between patients with APS and controls, and when such discrepancies were observed, the origin of this variability could not be determined. We hypothesize that the biological profile of antiphospholipid antibodies is responsible for the INR differences.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Stéphane ZUILY, MD, PhD
- 电话号码：+33 03 83 15 73 54
- 邮箱：stephane.zuily@univ-lorraine.fr
学习地点
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Vandœuvre-lès-Nancy、法国、54500
- CHRU de Nancy
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副研究员：
- Denis Wahl, MD, PhD
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首席研究员：
- Stéphane Zuily, MD, PhD
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接触：
- Aurélie Emmerich
- 电话号码：+33 03 83 15 36 14
- 邮箱：a.emmerich@chru-nancy.Fr
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副研究员：
- Virginie Dufrost, MD
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
Patients with APS treated with vitamin K antagonists (VKAs)
- Patients with an LA profile without aCL or anti-β2GPI (isolated LA)
- Patients with an LA and aCL + anti-β2GPI profile (triple positivity)
- Patients with another biological profile (other than isolated LA or triple positivity)
- Control patients without aCL or anti-β2GPI treated with VKAs
- Adult patients
- Patients who have undergone a prior clinical examination appropriate for the research
- Individuals who have received complete information on the organization of the research and have not objected to their participation and the use of their data
- Patients covered by a social security scheme
Exclusion Criteria:
- Patients with antiphospholipid syndrome (APS) not treated with vitamin K antagonists (VKAs)
- Women of childbearing age without effective contraception
Persons covered by Articles L. 1121-5, L. 1121-7, and L. 1121-8 of the French Public Health Code:
- Pregnant, parturient, or breastfeeding women
- Unemancipated minors
- Adults under legal protection (guardianship, curatorship, or protective supervision)
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Lupus Anticoagulant positive patients
Patients with isolated Lupus Anticoagulant positive test only
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Point of care testing INR using Coaguchek device
|
|
实验性的：Triple positive patients
Patients with triple positivity of antiphospholipid tests
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Point of care testing INR using Coaguchek device
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实验性的：Other antiphospholipid profile patients
Patients with another aPL profile other than isolated LAC or triple positivity
|
Point of care testing INR using Coaguchek device
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有源比较器：No antiphospholipid
Patients with no antiphospholipid antibodies
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Point of care testing INR using Coaguchek device
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Discrepancy between Coaguchek and venous INR
大体时间：At enrollment
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Percentage of patients per group with a fixed 20% discrepancy between a capillary INR measured on a Coagucheck© device and a venous INR according to subgroups and variables
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At enrollment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Discrepancy between MicroLine and venous INR
大体时间：At enrollment
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Percentage of patients per group with a fixed 20% discrepancy between a capillary INR measured on a MicroLine INR© device and a venous INR according to subgroups and variables
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At enrollment
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Discrepancy between Coaguchek and MicroLine INR
大体时间：At enrollment
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Percentage of patients per group with a fixed 20% discrepancy between a capillary INR measured on a Coagucheck© and MicroLine devices according to subgroups and variables
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At enrollment
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.