Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2026-02-28 @ 6:33 PM
Study NCT ID:
NCT03930459
Status:
TERMINATED
Last Update Posted:
2023-09-29
First Post:
2019-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Ex-situ Normothermic Perfusion Versus Cold Storage in the Transplant With Steatotic Liver Graft.
Sponsor:
Instituto de Investigacion Sanitaria La Fe
Organization:
Study Overview
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
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ORGANOXLAFE
Brief 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.
Detailed 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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: