Thrombin Generation Assay to Assess Thrombotic Risk in Nephrotic Patients

NCT05301829 | Unknown

• 1 other identifier: APHP220213
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Nephrotic Syndrome

Keywords

Nephrotic Syndrome; Thrombotic risk assessment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• \- Active anticoagulation treatment before TGT

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de Néphrologie et Dialyses, Hôpital Tenon

Paris, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Collection of citrated whole-blood samples three times during the timecourse of the disease.

MeSH Terms

Conditions

Nephrotic Syndrome

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Armance MARCHAL

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Armance MARCHAL, MD

CONTACT

1 56 01 60 43; armance.marchal@aphp.fr

Jean-Jacques BOFFA, MD, PhD

CONTACT

1 56 01 60 29; jean-jacques.boffa@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: March 31, 2022
• Study Start: April 1, 2022
• Primary Completion: October 31, 2022
• Study Completion: March 31, 2024
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

FR (1)