Porto-Sinusoidal Vascular DiseaseTRANSVASNCT05388409
Risk Factors for Portosinusoidal Vascular Disease in Kidney Transplant Recipients:
An observational study of Porto-Sinusoidal Vascular Disease, run by University Hospital, Caen at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Porto-Sinusoidal Vascular Disease
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 25 Oct 2021to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: CASE : PSVD after kidney transplantation. Controls : Kidney transplantation without PSVD and PSVD without kidney transplantation.
Who may be able to join
- PSVD (between january 2000 and december 2021) after kidney transplantation or
- Kidney transplantation without PSVD or
- PSVD without kidney transplantation
Who cannot join
- liver cirrhosis
- transplanted from an other organ
- thrombocytopenia and/or abnormal liver tests and/or hepatic dysmorphism and/or portal hypertension signs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Porto-Sinusoidal Vascular Disease
- Medical subject headings
- Idiopathic Noncirrhotic Portal Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CASE | Kidney transplanted patients with PSVD | |
| Control 1 | Kidney transplanted patients without PSVD | |
| Control 2 | patient with PVSD without transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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, ...).
Measured: 2 years
Secondary outcomes (3)
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.
Measured: 2 years
Biological, and evolutionary profiles.
Evolution of liver blood results : ASAT, ALAT, GGT (same units of measure)
Measured: 2 years
Evolution of liver function.
Aggregation of results (Bilirubin, Albumin, prothrombin rate) into Child Pugh Score.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start25 Oct 2021
- Primary completion7 Feb 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Porto-Sinusoidal Vascular DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05388409
- Sponsor's protocol ID
- TRANSVAS
- Acronym
- TRANSVAS
- Status last verified
- Feb 2024
- First submitted
- 29 Apr 2022
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Portosinusoidal Vascular Disease in Kidney Transplant Recipients: Case-control Study
- ClinicalTrials.gov ID
- NCT05388409
- Acronym / sponsor ID
- TRANSVAS / TRANSVAS
- Conditions
- Porto-Sinusoidal Vascular Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 7 Feb 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 24 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CASE | – | –Kidney transplanted patients with PSVD |
| Control 1 | – | –Kidney transplanted patients without PSVD |
| Control 2 | – | –patient with PVSD without transplantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CASE : PSVD after kidney transplantation. Controls : Kidney transplantation without PSVD and PSVD without kidney transplantation.
Key inclusion criteria (3 listed)
- PSVD (between january 2000 and december 2021) after kidney transplantation or
- Kidney transplantation without PSVD or
- PSVD without kidney transplantation
Key exclusion criteria (3 listed)
- liver cirrhosis
- transplanted from an other organ
- thrombocytopenia and/or abnormal liver tests and/or hepatic dysmorphism and/or portal hypertension signs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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, ...).
3 secondary outcomes
Clinical profiles.
Time frame: 2 years
Biological, and evolutionary profiles.
Time frame: 2 years
Evolution of liver function.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Porto-Sinusoidal Vascular Disease
Not yet recruitingObservational study
Study on Clinicopathological Features, Influencing Factors and Clinical Outcomes in Patients With PSVD
Porto-Sinusoidal Vascular Diseases
Not yet recruiting
Multiparametric Ultrasound for the Noninvasive Diagnosis of Porto-sinusoidal Vascular Liver Disorder
Porto-sinusoidal Vascular Liver Disorder, Liver Cirrhosis
RecruitingObservational study
TIPS for Complicated Portal Hypertension Related to Porto-Sinusoidal Vascular Disease
TIPS, Portal Hypertension
RecruitingObservational study
Non-invasive Tools for PSVD Diagnosis
Non-Cirrhotic Portal Hypertension, Porto-Sinusoidal Vascular Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Porto-Sinusoidal Vascular Disease, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To highlight risk factors significantly related to the occurrence of PSVD in renal transplant recipients. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.