Skip to main content
OpenTrials
Completed

NCT Number: NCT05388409

Risk Factors for Portosinusoidal Vascular Disease in Kidney Transplant Recipients:

To look for the factors of exposure present prior to the onset of Porto-Sinusoidal Vascular Disease (PSVD) and which can lead to the occurrence of PSVD after renal transplantation, and therefore to consider the identification of risk factors, in order to prevent or detect early signs of portal hypertention in predisposed patients and improve their prognosis.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Porto-Sinusoidal Vascular Disease Digestive System Diseases Hypertension, Portal Idiopathic Noncirrhotic Portal Hypertension Liver Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu de Caen

Caen, Calvados, 14033, France

About this study

Porto-Sinusoidal Vascular Disease (PSVD) is a heterogeneous clinico-pathological entity characterized by alterations in small liver vessels. The most common is known as "nodular regenerative hyperplasia (NRH)". Patients with PSVD especially NRH can developed portal hypertension. An acute portal thrombosis occurs in 1/3 of patients at five years. In case of portal hypertension, 10 years survival decreases down to 56 to 82%. De novo NRH has been described after liver transplantation (1 to 1.4% in adults, 8.2% in kids), and also in small series of kidney, cardiac and bone marrow transplantation. Prevalence is estimated to be 0.5% after kidney transplantation.

Several risks factors have been related to PSVD (infections, Immune-mediated disorders, haematological diseases, prothrombotic disorders, drugs such as azathioprine, genetic diseases). In transplantation, mechanical vascular factors, drugs, virus, immunogenetic and immunologic factors have been suggested, but none of them are well established.

The study aims to determined risk factors which can lead to PSVD in kidney transplant recipients, in order to prevent or to early detect portal hypertension and improve the prognosis of these patients. A case-control multicentric retrospective study will be done to compare adult kidney transplant recipients with PSVD with or without portal hypertension, to adult kidney transplant recipients without evidence for PSVD (matched according to the date of kidney transplantation of the case ± 2 years), and to non-transplanted adults with PSVD. Kidney transplant cases and controls will be recruited from French hepatogastroenterology and nephrology units. PSVD non transplanted controls will be recruited from the Beaujon Hospital database dedicated to liver vascular diseases.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • PSVD (between january 2000 and december 2021) after kidney transplantation or
  • Kidney transplantation without PSVD or
  • PSVD without kidney transplantation

Exclusion criteria

  • liver cirrhosis
  • transplanted from an other organ
  • thrombocytopenia and/or abnormal liver tests and/or hepatic dysmorphism and/or portal hypertension signs

Treatment and study plan

Primary outcomes

  1. To highlight risk factors significantly related to the occurrence of PSVD in renal transplant recipients.

    Time frame: 2 years

    Blood samples histrory results analyse to identify usual prothrombic factors associated (or not) to PSVD (e.g;, myeloproliferative syndrome, Factor V Leiden mutation, blood group, ...).

Secondary outcomes

  1. Clinical profiles.

    Time frame: 2 years

    Natural history of PSVD in renal transplant recipients included in the study and in control group (medical history, complications of portal hypertension as esophageal varices, hepatic encephalopathy, TIPS procedure, ascites..., imaging results...) by studying medical record.

  2. Biological, and evolutionary profiles.

    Time frame: 2 years

    Evolution of liver blood results : ASAT, ALAT, GGT (same units of measure)

  3. Evolution of liver function.

    Time frame: 2 years

    Aggregation of results (Bilirubin, Albumin, prothrombin rate) into Child Pugh Score.

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

Risk Factors for Portosinusoidal Vascular Disease in Kidney Transplant Recipients: Case-control Study

Acronym: TRANSVAS

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 24, 2022
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.