Thrombin Generation Assay to Assess Thrombotic Risk in Nephrotic Patients (TGANephrotic)
Thrombin Generation Assay to Assess Thrombotic Risk and the Evolution of the Hypercoagulability Profile of Patients With Nephrotic Syndrome
The thromboembolic risk is increased during the nephrotic syndrome (NS) with an incidence of deep vein thrombosis 15%, pulmonary embolism of 10-30% and renal vein thrombosis of 25-37%. There is a hemostatic imbalance with urinary leakage of anticoagulant factors and increased hepatic synthesis of procoagulant factors, platelet hyperaggregability and a decrease in fibrinolytic activity. However, the identification of patients requiring anticoagulant prophylaxis remains imprecise.The thromboembolic risk is higher when the NS is related to extramembranous glomerulonephritis comparatively to others glomerulopathies. The reason of this difference is not still known. This risk increase with SN's severity and therefore with the decrease of albuminemia. Moreover, few studies have evaluated anticoagulant treatment efficacy during a NS, which clinical benefit depends also on hemorrhagic risk specific of each patient. Thus, the determination of the thrombotic risk and the modalities of anticoagulation are variable and perfectible during the NS.
We propose to use the thrombin generation test (TGT) to quantify the thromboembolic risk in patients with a NS and to follow its evolution during prophylactic anticoagulation and after remission of NS.
研究概览
地位
条件
详细说明
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名:Armance MARCHAL, MD
- 电话号码:+33 1 56 01 60 43
- 邮箱:armance.marchal@aphp.fr
研究联系人备份
- 姓名:Jean-Jacques BOFFA, MD, PhD
- 电话号码:+33 1 56 01 60 29
- 邮箱:jean-jacques.boffa@aphp.fr
学习地点
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Paris、法国
- Service de Néphrologie et Dialyses, Hôpital Tenon
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接触:
- Armance MARCHAL, MD
- 电话号码:+33 1 56 01 60 29
- 邮箱:armance.marchal@aphp.fr
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Nephrotic syndrome
- Known cause of nephrotic syndrome (renal biopsy and/or positive anti-PLA2R)
Exclusion Criteria:
- Active anticoagulation treatment before TGT
学习计划
研究是如何设计的?
设计细节
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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To assess the prognosticity of TGT in predicting the occurrence of a thromboembolic event at 6 months.
大体时间:6 months
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Number of thrombotic events at 6 months of follow-up
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6 months
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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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Variation of TGT parameters (data combined considering latency, velocity, peak, amount of total thrombin formed) during the follow-up
大体时间:Maximum 6 months (when albumin > 30 g/l)
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To calculate the difference of TGT parameters between the time of acute phase of NS (at diagnosis = inclusion), and after NS remission.
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Maximum 6 months (when albumin > 30 g/l)
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Compare the theoric indications for anticoagulation therapy according to TGT parameters with those of the Lin R algorithm and "Kidney Disease: Improving Global Outcomes" (KDIGO) 2021
大体时间:At diagnosis = at inclusion
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Percentage of anticoagulated patients versus theoric number, based on TGT results and available algorithms
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At diagnosis = at inclusion
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合作者和调查者
调查人员
- 首席研究员:Armance MARCHAL、Assistance Publique - Hôpitaux de Paris
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
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
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