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临床试验/NCT05301829
NCT05301829Unknown不适用

Thrombin Generation Assay to Assess Thrombotic Risk and the Evolution of the Hypercoagulability Profile of Patients With Nephrotic Syndrome

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
75
试验地点
1
主要终点
To assess the prognosticity of TGT in predicting the occurrence of a thromboembolic event at 6 months.

研究概览

简要总结

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.

详细描述

Thrombin generation test will be performed prospectively in nephrotic patients with various diseases (Minimal Change Disease (MCD), Malignant Nephrosclerosis (MN), Focal Segmental GlomeruloSclerosis (FSGS), diabetic glomerulopathy...) at diagnosis, during anticoagulant treatment (D8±3) and after disease remission (M6).

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

入选标准

  • Nephrotic syndrome
  • Known cause of nephrotic syndrome (renal biopsy and/or positive anti-PLA2R)

排除标准

  • Active anticoagulation treatment before TGT

结局指标

主要结局

To assess the prognosticity of TGT in predicting the occurrence of a thromboembolic event at 6 months.

时间窗: 6 months

Number of thrombotic events at 6 months of follow-up

次要结局

  • Variation of TGT parameters (data combined considering latency, velocity, peak, amount of total thrombin formed) during the follow-up(Maximum 6 months (when albumin > 30 g/l))
  • 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(At diagnosis = at inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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