Status:
UNKNOWN
Comparison of Hypothermic Versus Normothermic Ex-vivo Preservation.
Lead Sponsor:
Azienda Ospedaliero, Universitaria Pisana
Collaborating Sponsors:
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Conditions:
End Stage Liver DIsease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Study groups: The study is a multicenter (Pisa and Milan), prospective, randomized study comparing D-HOPE (HMP) vs NMP in DCD and ECD-DBD (extended criteria brain-dead donors). Once a DCD or a DBD wi...
Detailed Description
The persistent mismatch between patients waiting for a liver transplant (LT) and grafts availability promoted the use of donation after circulatory death (DCD). Italian law requires 20 minutes of cont...
Eligibility Criteria
Inclusion
- GRAFT:
- Inclusion criteria:
- DCD:
- no absolute contraindications as per Italian National Transplant center (CNT)
- donor age ≤70 years
- witnessed and documented cardiac arrest
- macro-vescicular steatosis \<30% at liver biopsy
- necrosis \<5% at liver biopsy
- fibrosis \<2 as per Ishak's score at liver biopsy
- arteriolar thickening \<60% at liver biopsy
- WIT ≤160 minutes
- ALT \<1000 UI/L during NRP
- downward trend lactate during NRP
- DBD:
- no absolute contraindications as per Italian National Transplant center (CNT)
- donor age \> 70 years
- macro-steatosis between 30 and 50% at liver biopsy
- Exclusion criteria:
- DCD:
- absolute contraindications as per Italian National Transplant center (CNT)
- donor age \>70 years
- macro-vescicular steatosis \>30% at liver biopsy
- necrosis \>5% at liver biopsy
- fibrosis \>2 as per Ishak's score at liver biopsy
- severe macroangiopathy (arteriolar thickening \>60% at liver biopsy)
- WIT \>160 minutes
- ALT \>1000 UI/L during NRP
- uptrend lactate during NRP
- DBD:
- absolute contraindications as per Italian National Transplant center (CNT)
- donor age \< 70 years
- macro-steatosis between \> 50% at liver biopsy
- RECIPIENTS
- Inclusion criteria:
- Subject must be greater than or equal to 18 years of age.
- Subject with end-stage liver disease who is actively listed for primary liver transplantation
- Subject, or a legally authorized representative, has given informed consent to participate in the study
- Exclusion criteria:
- Subject is currently listed as a UNOS status 1A.
- Subject is requiring oxygen therapy via ventilator/respiratory support.
- Subject is planned to undergo simultaneous solid organ transplant.
- Subject is pregnant at the time of transplant.
- Subject MELD score 25 or higher
- Subject receives re-transplantation of liver.
- Any medical conditions contro-indicating the use of DCD grafts at transplant surgeon/hepatologist evaluation
Exclusion
Key Trial Info
Start Date :
December 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04744389
Start Date
December 15 2020
End Date
March 31 2023
Last Update
July 26 2022
Active Locations (1)
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1
UO Chirurgia Epatica e del Trapianto di Fegato
Pisa, Italy, 56124