Thrombin Generation Assay to Assess Thrombotic Risk in Nephrotic Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Nephrotic Syndrome

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Nephrotic syndrome Known cause of nephrotic syndrome (renal biopsy and/or positive anti-PLA2R) Exclusion Criteria: - Active anticoagulation treatment before TGT

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the prognosticity of TGT in predicting the occurrence of a thromboembolic event at 6 months. | Number of thrombotic events at 6 months of follow-up | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of TGT parameters (data combined considering latency, velocity, peak, amount of total thrombin formed) during the follow-up | To calculate the difference of TGT parameters between the time of acute phase of NS (at diagnosis = inclusion), and after NS remission. | 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 | Percentage of anticoagulated patients versus theoric number, based on TGT results and available algorithms | At diagnosis = at inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nephrotic Syndrome, Thrombotic risk assessment