Hypothermic Machine Perfusion for Liver Graft Preservation

Summary

The goal of this clinical trial is to evaluate whether hypothermic machine perfusion improves liver graft preservation and post-transplant outcomes compared to conventional static cold storage in adult patients undergoing liver transplantation. This study focuses on liver grafts from deceased donors, including those with extended criteria, which are more susceptible to ischemia-reperfusion injury and early graft dysfunction.

The main questions it aims to answer are:

Does hypothermic machine perfusion reduce ischemia-reperfusion injury and improve early graft function after liver transplantation? Does this preservation strategy improve clinical outcomes, including graft survival, complication rates, and post-transplant recovery, compared to static cold storage?

Researchers will compare hypothermic machine perfusion (ex situ, oxygenated perfusion at low temperature) to standard static cold storage to assess differences in graft preservation quality and post-transplant outcomes.

Participants will:

Receive a liver graft preserved either by hypothermic machine perfusion or static cold storage, according to a 1:1 randomization protocol Undergo standard liver transplantation procedures Be followed after transplantation with clinical, laboratory, imaging, and biomarker assessments at predefined time points (7 days, 30 days, 6 months, and 1 year)

Additional evaluations will include biochemical markers of liver function, inflammatory and immunological mediators, mitochondrial function assessment, and histological analysis to better characterize graft injury and recovery.

Conditions

• Liver Transplant
• Liver Failure

Interventions

DEVICE

Hypothermic Machine Perfusion

Hypothermic machine perfusion of the liver graft is performed prior to transplantation using an ex situ perfusion system under controlled conditions, in which an oxygenated perfusate is circulated through the liver graft vasculature.

PROCEDURE

Static Cold Storage

Liver graft preservation using conventional static cold storage under hypothermic conditions until transplantation.

Sponsors & Collaborators

• XVIVO Perfusion

  collaborator INDUSTRY

• University of Sao Paulo General Hospital

  lead OTHER

Principal Investigators

• Wellington Andraus, MD, PhD · Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC-FMUSP)

• Rubens Macedo Junior, MD, PhD · Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC-FMUSP)

• Alexandre Santana, PhD · Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC-FMUSP)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-07

Primary Completion

2027-05-07

Completion

2028-05-07

Countries

• Brazil

Study Locations