Status:
COMPLETED
Liver Graft Viability Assessment During Normothermic Regional Perfusion
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Liver Transplant Failure
Eligibility:
All Genders
18-66 years
Phase:
NA
Brief Summary
With the increasing shortage of available donor organs, liver transplantation from donation after circulatory death (DCD) has been established in many countries to offer a therapeutic strategy for pat...
Eligibility Criteria
Inclusion
- All cDCD liver grafts allocated to one of the study centers undergoing NRP and where procurement of any abdominal organ is initiated
- Procurement performed by one of the four transplant teams
- non opposition by the donor or his family to organ donation
- non opposition by the recipient to participate in the study
- All Adult recipients on the waiting list for liver transplantation elligible for a liver procured after circulatory death according to the Agence de la Biomedecine.
- Recipient, aged at least 18 years and less than 66 years,
- Awaiting a first transplantation,
- Recipients considered not too sick to cope with post-reperfusion syndrome not ventilated, no inotropic agents ...)
- No major surgical history and no portal vein thrombosis; To minimize cold and recipient ischemic time (anastomotic time), patients where the recipient hepatectomy was predicted to be difficult were excluded
- With a MELD score ≤ 25
- Patient has been duly informed and has consented. Although the results of transplantations after DCD have very clearly improved over the years, clear information for the recipient and the provision of informed consent both remain essential. This means making clear to the patient the risk of primary nonfunction as well as of ischemic cholangiopathy and early arterial thrombosis.
Exclusion
- \-- cDCD procurement where NRP fails or is not initiated due to technical reasons
- \- Graft reallocation after procurement to a transplant team not included in the study
Key Trial Info
Start Date :
August 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 26 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05361044
Start Date
August 22 2022
End Date
June 26 2025
Last Update
July 25 2025
Active Locations (4)
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1
Department of HPB surgery and liver transplantation
Clichy, France, 92210
2
Department of general surgery and liver transplantation, Croix-Rousse University Hospital 103 Boulevard de la Croix Rousse
Lyon, France, 69004
3
Department of HPB surgery and liver transplantation
Paris, France, 75013
4
Department of HPB and Digestive Surgery
Rennes, France, 35000