Clinical trial NCT05301829: Thrombin Generation Assay to Assess Thrombotic Risk in Nephrotic Patients
Official title: Thrombin Generation Assay to Assess Thrombotic Risk and the Evolution of the Hypercoagulability Profile of Patients With Nephrotic Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nephrotic Syndrome
Keywords: Nephrotic Syndrome
Thrombotic risk assessment
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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: 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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

- Active anticoagulation treatment before TGT

Primary outcomes:
measure: To assess the prognosticity of TGT in predicting the occurrence of a thromboembolic event at 6 months.
timeFrame: 6 months
Secondary outcomes:
measure: Variation of TGT parameters (data combined considering latency, velocity, peak, amount of total thrombin formed) during the follow-up
timeFrame: Maximum 6 months (when albumin > 30 g/l)
measure: 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
timeFrame: At diagnosis = at inclusion
Other outcomes:
Locations:
city: Paris
country: France
facility: Service de Néphrologie et Dialyses, Hôpital Tenon
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Armance MARCHAL
role: PRINCIPAL_INVESTIGATOR
References: