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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.
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).
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| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
- Active anticoagulation treatment before TGT
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Patients with nephrotic syndrome defined by albuminemia <3 g/dl and urinary protein/creatinine > 3g/g) admitted in the nephrology department of Tenon hospital; etiological diagnosis available; consenting to research and whose treatment and follow-up will be possible for at least 6 months.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Armance MARCHAL, MD | Contact | 1 56 01 60 43 | +33 | armance.marchal@aphp.fr |
| Jean-Jacques BOFFA, MD, PhD | Contact | 1 56 01 60 29 | +33 | jean-jacques.boffa@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Armance MARCHAL | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Néphrologie et Dialyses, Hôpital Tenon | Paris | France |
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| ID | Term |
|---|---|
| D009404 | Nephrotic Syndrome |
| ID | Term |
|---|---|
| D009401 | Nephrosis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Collection of citrated whole-blood samples three times during the timecourse of the disease.
| 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 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |