Efficacy of Ex-situ Normothermic Perfusion Versus Cold Storage in the Transplant With Steatotic Liver Graft.
NCT03930459 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7
Last updated 2023-09-29
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.
Conditions
- Liver Transplant
Interventions
- 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.
Sponsors & Collaborators
-
Instituto de Investigacion Sanitaria La Fe
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-04-26
- Primary Completion
- 2023-04-04
- Completion
- 2023-04-04
Countries
- Spain
Study Locations
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