- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05301829
Thrombin Generation Assay to Assess Thrombotic Risk in Nephrotic Patients (TGANephrotic)
Thrombin Generation Assay to Assess Thrombotic Risk and the Evolution of the Hypercoagulability Profile of Patients With Nephrotic Syndrome
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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiekontakt
- Navn: Armance MARCHAL, MD
- Telefonnummer: +33 1 56 01 60 43
- E-post: armance.marchal@aphp.fr
Studer Kontakt Backup
- Navn: Jean-Jacques BOFFA, MD, PhD
- Telefonnummer: +33 1 56 01 60 29
- E-post: jean-jacques.boffa@aphp.fr
Studiesteder
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Paris, Frankrike
- Service de Néphrologie et Dialyses, Hôpital Tenon
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Ta kontakt med:
- Armance MARCHAL, MD
- Telefonnummer: +33 1 56 01 60 29
- E-post: armance.marchal@aphp.fr
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Nephrotic syndrome
- Known cause of nephrotic syndrome (renal biopsy and/or positive anti-PLA2R)
Exclusion Criteria:
- Active anticoagulation treatment before TGT
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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To assess the prognosticity of TGT in predicting the occurrence of a thromboembolic event at 6 months.
Tidsramme: 6 months
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Number of thrombotic events at 6 months of follow-up
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6 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Variation of TGT parameters (data combined considering latency, velocity, peak, amount of total thrombin formed) during the follow-up
Tidsramme: Maximum 6 months (when albumin > 30 g/l)
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To calculate the difference of TGT parameters between the time of acute phase of NS (at diagnosis = inclusion), and after NS remission.
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Maximum 6 months (when albumin > 30 g/l)
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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
Tidsramme: At diagnosis = at inclusion
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Percentage of anticoagulated patients versus theoric number, based on TGT results and available algorithms
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At diagnosis = at inclusion
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Armance MARCHAL, Assistance Publique - Hôpitaux de Paris
Studierekorddatoer
Studer hoveddatoer
Studiestart (Forventet)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- APHP220213
Plan for individuelle deltakerdata (IPD)
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