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

Liver Transplant Clinical Trial

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

Status Terminated

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Liver Transplant

• NCT number: NCT03930459
• Study type: Interventional
• Source: Instituto de Investigacion Sanitaria La Fe
• Status: Terminated
• Phase: N/A
• Start date: April 26, 2019
• Completion date: April 4, 2023