Risk Factors for Portosinusoidal Vascular Disease in Kidney Transplant Recipients: (TRANSVAS)

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

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.

Study Overview

• Status: Completed
• Conditions: Porto-Sinusoidal Vascular Disease

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• France
  • Calvados
    • Caen, Calvados, France, 14033
      • CHU de Caen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

CASE : PSVD after kidney transplantation. Controls : Kidney transplantation without PSVD and PSVD without kidney transplantation.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
CASE; Kidney transplanted patients with PSVD
Control 1; Kidney transplanted patients without PSVD
Control 2; patient with PVSD without transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To highlight risk factors significantly related to the occurrence of PSVD in renal transplant recipients.	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, ...).	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical profiles.	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 years
Biological, and evolutionary profiles.	Evolution of liver blood results : ASAT, ALAT, GGT (same units of measure)	2 years
Evolution of liver function.	Aggregation of results (Bilirubin, Albumin, prothrombin rate) into Child Pugh Score.	2 years

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2021
• Primary Completion (Actual): February 7, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: April 29, 2022
• First Submitted That Met QC Criteria: May 23, 2022
• First Posted (Actual): May 24, 2022

Study Record Updates

• Last Update Posted (Actual): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases
• Other Study ID Numbers: TRANSVAS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No