Status:
NOT_YET_RECRUITING
Normothermic Oxygenated Perfusion (NMP) Viability Testing Before Transplantation of Discarded Livers
Lead Sponsor:
Rennes University Hospital
Conditions:
Organ Transplantation
Liver Dysfunction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Liver transplantation (LT) is a highly effective treatment for end-stage liver disease and early-stage primary liver cancer. As such, the demand for donor livers greatly exceeds supply; in 2021 in Fra...
Detailed Description
Liver transplantation (LT) is a highly effective treatment for end-stage liver disease and early-stage primary liver cancer. As such, the demand for donor livers greatly exceeds supply; in 2021 in Fra...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA :
- FOR LIVER DONORS
- Donation after brainstem death (DBD)
- Liver graft refused by 5 different transplant centres and after rescue allocation ("hors tour")
- FOR LIVER TRANSPLANT RECIPIENTS
- ≥ 18 years old
- Candidates for a first elective liver transplantation (patients with a pre-transplant work-up excluding: re-transplantation, emergency transplantation (e.g. fulminant hepatitis), multi-organ or heterotopic transplantation)
- UNOS status IV (non-ventilated, no vasopressor support)
- Absence of renal insufficiency defined as a GFR of less than 60 mL/min/1.73 m² for three months or more
- MELD Score ≤ 25
- Willing and able to attend follow-up examinations
- Having signed an informed consent document
- NON-INCLUSION CRITERIA:
- FOR LIVER DONORS
- Macroscopic features of advanced fibrosis or cirrhosis at procurement
- Transplantation using a split graft, in situ or ex situ
- Estimated cold ischemic time greater than 8 hours (5 hours maximum of graft transport in cold ischemia)
- FOR LIVER TRANSPLANT RECIPIENTS
- Mentally or legally incapacitated
- Transplantation for fulminant hepatic failure
- Early or late re-transplantation
- Combined liver transplant with any other organ, en-bloc or not
- Heterotopic liver transplantation
Exclusion
Key Trial Info
Start Date :
December 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 15 2029
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT06950398
Start Date
December 15 2025
End Date
June 15 2029
Last Update
August 15 2025
Active Locations (6)
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1
APHP_Hôpital Beaujon
Clichy, France, 92110
2
Hôpital Croix Rousse
Lyon, France, 69003
3
CHU de Montpellier
Montpellier, France, 34090
4
CHU de Rennes PONTCHAILLOU
Rennes, France, 35000