Tissue Analysis of Liver Grafts as a Predictor of Transplant Outcome.

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Enrolling

Conditions: Hepatic Transplantation; Rejection; Transplant, Liver

Treatments: Diagnostic Test: RT-PCR; Diagnostic Test: histochemical and immunohistochemical analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT06717542

RC-2022-2773274 (Other Grant/Funding Number)

donorHOPE_2022

Details and patient eligibility

About

Despite the good clinical results in terms of outcome with the application of HOPE prior to liver transplantation, very little is still known about the phenotypic and molecular changes that occur during perfusion/preservation during HOPE, particularly with regard to endothelial trophism and activation. Delving into these aspects would be very useful to allow personalised perfusion treatments in the future, thus improving the outcome of transplantation.

Full description

The primary aim of the study is the identification of specific 'endothelial signatures' (markers on tissue with immunohistochemistry and gene expression with RT-PCR) in liver grafts after HOPE treatment, predictive of transplant outcome. Interventional study without drug, including two cohorts of patients: (1) liver donors, on whom an allocation biopsy for organ quality will be performed (as standard of care); (2) liver recipients (from donors in cohort 1) on whom a study-specific biopsy will be performed as soon as the transplant has taken place (after vascular anastomoses with organ revascularisation). The study-specific biopsy constitutes the intervention of the study; patients will be treated according to the judgement of the physician and the information reported in the Technical Data Sheet of each product of any concomitant therapies administered according to clinical practice.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• For Donors:

Availability of enough tissue for histological, immunohistochemical and RT-PCR analysis.

• HOPE performed on the liver graft prior to transplantation.
• For Recipients:
• Availability of enough tissue for histological, immunohistochemical and RT-PCR analysis.
• Age greater than/equal to 18 years.

Exclusion criteria

• None

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Organ donors

Other group

Description:

organ donors (legally deceased, brain death or cardiac death)

Treatment:

Diagnostic Test: histochemical and immunohistochemical analysis

Diagnostic Test: RT-PCR

Organ recipients

Other group

Description:

Organ recipients

Treatment:

Diagnostic Test: histochemical and immunohistochemical analysis

Diagnostic Test: RT-PCR