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

Sponsor
University Hospital, Caen (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05388409
Collaborator
(none)
12
Enrollment
1
Location
8.1
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    12 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Risk Factors for Portosinusoidal Vascular Disease in Kidney Transplant Recipients: Case-control Study
    Actual Study Start Date :
    Oct 25, 2021
    Actual Primary Completion Date :
    Jan 27, 2022
    Anticipated Study Completion Date :
    Jun 30, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    CASE

    Kidney transplanted patients with PSVD
    Control 1

    Kidney transplanted patients without PSVD
    Control 2

    patient with PVSD without transplantation

    Outcome Measures

    Primary Outcome Measures

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

    1. Clinical profiles. [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. [2 years]

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

    3. Evolution of liver function. [2 years]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chu de Caen Caen Calvados France 14033

    Sponsors and Collaborators

    • University Hospital, Caen

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Isabelle OLLIVIER, Principal Investigator, University Hospital, Caen
    ClinicalTrials.gov Identifier:
    NCT05388409
    Other Study ID Numbers:
    • TRANSVAS
    First Posted:
    May 24, 2022
    Last Update Posted:
    May 24, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Vascular Diseases

    Study Results

    No Results Posted as of May 24, 2022