Efficacy of Ex-situ Normothermic Perfusion Versus Cold Storage in the Transplant With Steatotic Liver Graft.

Instituto de Investigacion Sanitaria La Fe7 enrolled

Overview

Prospective, randomized, controlled clinical trial to determine the overall efficacy of normothermic machine perfusion (NMP) for steatotic liver preservation versus traditional static cold storage (SCS), in 50 liver transplant recipients with 1-year follow-up.

This is a prospective, randomized, controlled clinical trial comparing static cold storage (SCS) versus normothermic machine perfusion (NMP) for organ preservation before liver transplantation with steatotic livers (between 30 % and 60% of histologic macrovesicular steatosis), in order to: Main Objective: To compare the effect of NMP versus SCS in preventing preservation injury and graft dysfunction, as measured by highest transaminase levels during the first week after liver transplantation. Secondary Objectives: * To compare graft and patient survival between the NMP and SCS steatotic livers. * To compare the liver biochemical function between the NMP and SCS steatotic livers. * To compare the physiological response to the reperfusion between the NMP and SCS steatotic livers. * To compare the evidence of reperfusion injury between the NMP and SCS steatotic livers. * To compare the evidence of ischemic cholangiopathy between the NMP and SCS steatotic livers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Liver Transplant

Interventions

Static cold storage (SCS)PROCEDURE

The liver is flushed and cooled with specialist preservation fluid, then stored in an icebox.

Normothermic machine perfusion (NMP)DEVICE

During NMP, the liver is perfused with oxygenated blood, medications and nutrients at normal body temperature to maintain a physiological milieu.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: LIVER DONOR: * Donors older than 16 years * Liver donation grafts due to brain death * Steatosis confirmed by histological study (between 30% and 60% of macrovesicular steatosis) LIVER RECIPIENT: * Adult patients (18 years or older) * Active liver transplant waiting list candidate * Able to give informed consent Exclusion Criteria: LIVER DONOR: * Living donors * Liver destined to the transplant "split" * Donor age \<16 years * Donation after death due to asystole. * When the biopsy establishes a steatosis ≥ 50%, patients who fulfill at least 3 of the following 5 risk factors will be excluded: Transaminases (AST and ALT) ≥ 200 U / L; Age ≥ 55 years; Hypernatremia ≥ 155 mEq / L; Cardiovascular risk factors, at least 2 of the following 5: DM, HTA, IMC ≥ 35, Active smoking, ischemic stroke; Days of stay in ICU ≥ 4 days with vasoactive drugs (noradrenaline or dobutamine at any dose) LIVER RECIPIENT: * Age under 18 * Acute/fulminant hepatic failure * Transplant of more than one organ (for example, liver and kidney) * Rejection of informed consent * Unable to give informed consent

Locations (1)

Hospital Universitario y Politécnico La Fe

Valencia, Spain

Outcomes

Primary Outcomes

Peak of transaminases (AST and ALT)

Time frame: Day 1 post-transplant.

Peak of transaminases (AST and ALT)

Time frame: Day 3 post-transplant.

Peak of transaminases (AST and ALT)

Time frame: Day 5 post-transplant.

Peak of transaminases (AST and ALT) l

Time frame: Day 7 post-transplant.

Secondary Outcomes

Primary graft failure

Primary graft failure: irreversible graft dysfunction that requires emergency hepatic replacement during the first 10 days after liver transplantation, in the absence of technical or immunological causes.

Time frame: Day 10 post-transplant.

Graft survival

Time frame: Day 30 post-transplant, month 6 post-transplant, month 12 post-transplant.

Patient survival

Time frame: Day 30 post-transplant, month 6 post-transplant, month 12 post-transplant.

Post-reperfusion syndrome, measured by mean arterial pressure (MAP) levels

Post-reperfusion syndrome is defined as a decrease in mean arterial pressure (MAP) of more than 30% of the baseline value for more than one minute during the first five minutes after reperfusion. This will be evaluated in the context of the use of vasopressors.

Time frame: During the first 5 minutes after reperfusion

Biochemical function of the liver measured by Bilirubin post-transplant levels

Data from ClinicalTrials.gov

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