Trials / Terminated
TerminatedNCT03930459
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.
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 7 (actual)
- Sponsor
- Instituto de Investigacion Sanitaria La Fe · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Static cold storage (SCS) | The liver is flushed and cooled with specialist preservation fluid, then stored in an icebox. |
| DEVICE | Normothermic machine perfusion (NMP) | During NMP, the liver is perfused with oxygenated blood, medications and nutrients at normal body temperature to maintain a physiological milieu. |
Timeline
- Start date
- 2019-04-26
- Primary completion
- 2023-04-04
- Completion
- 2023-04-04
- First posted
- 2019-04-29
- Last updated
- 2023-09-29
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT03930459. Inclusion in this directory is not an endorsement.