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

Clinical Trial to Compare the Efficacy of Ex-situ Normothermic Perfusion With Cold Storage in the Transplant With Steatotic Liver Graft.

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.

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