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Thrombin Generation Assay to Assess Thrombotic Risk in Nephrotic Patients

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05301829
Acronym
TGANephrotic
Enrollment
75
Registered
2022-03-31
Start date
2022-04-01
Completion date
2024-03-31
Last updated
2022-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nephrotic Syndrome

Keywords

Nephrotic Syndrome, Thrombotic risk assessment

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).

Interventions

None listed

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

\- Active anticoagulation treatment before TGT

Design outcomes

Primary

MeasureTime frameDescription
To assess the prognosticity of TGT in predicting the occurrence of a thromboembolic event at 6 months.6 monthsNumber of thrombotic events at 6 months of follow-up

Secondary

MeasureTime frameDescription
Variation of TGT parameters (data combined considering latency, velocity, peak, amount of total thrombin formed) during the follow-upMaximum 6 months (when albumin > 30 g/l)To calculate the difference of TGT parameters between the time of acute phase of NS (at diagnosis = inclusion), and after NS remission.
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) 2021At diagnosis = at inclusionPercentage of anticoagulated patients versus theoric number, based on TGT results and available algorithms

Countries

France

Contacts

Primary ContactArmance MARCHAL, MD
armance.marchal@aphp.fr1 56 01 60 43
Backup ContactJean-Jacques BOFFA, MD, PhD
jean-jacques.boffa@aphp.fr1 56 01 60 29

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026