Post Static Cold Storage Normothermic Machine Liver Perfusion
- Conditions
- Liver Transplantation
- Registration Number
- NCT03176433
- Lead Sponsor
- University of Oxford
- Brief Summary
The aim of this study is to assess the safety and feasibility of a short period of cold storage prior to normothermic machine perfusion in adult liver transplantation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- Donors over the age of 16 years.
- Liver allografts from donation after brain death (DBD), standard and extended criteria donors. (SCD, ECD) and donation after circulatory death (DCD) donors.
- Liver must be perfused on OrganOx metra perfusion device within 8 hours of in situ cold perfusion.
- The perfusion should last a minimum of 4 hours and maximum of 24 hours.
Donor
- Living donors.
- Liver being transplanted as part of a multi-organ transplant (eg liver and kidney).
- Liver intended for split transplant.
- Donor age <16 years
- Liver which investigator is unwilling to recruit to study.
- Any liver in which logistics prevent perfusion on the OrganOx metra perfusion device within 8 hours of in situ cold perfusion.
Recipient Inclusion Criteria:
- Adult patients (18 years or more).
- Active on the waiting list for liver transplantation.
- Able to give informed consent.
Recipient Exclusion Criteria:
- Age less than 18 years.
- Acute/fulminant liver failure.
- Transplantation of more than one organ (e.g. liver and kidney).
- Refusal of informed consent.
- Unable to give informed consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Patient and Graft Survival 30 days Patient survival after liver transplantation and liver graft survival will be assessed at 30-days post-op as a composite outcome measure. This will be recorded as yes/no outcome.
- Secondary Outcome Measures
Name Time Method Primary non-function 10 days This is irreversible graft dysfunction requiring emergency liver replacement during the first 10 days after liver transplantation, in the absence of technical or immunological causes.
This will be compared with matched controls of livers undergoing continuous NMP and SCSAdverse events, transplantation and organ discard rates. 30 days This composite outcome aims to establish safety and feasibility as well as organ utilisation. It will be compared with matched controls of livers undergoing continuous NMP and SCS
Biliary investigation or intervention 6 months In order to capture the incidence of ischaemic cholangiopathy, any biliary investigation (such as magnetic resonance imaging) or intervention (such as endoscopic retrograde cholangiopancreatography) will be recorded and compared with matched controls of livers undergoing continuous NMP and SCS
Patient and Graft Survival 12 months Patient survival after liver transplantation and liver graft survival will be assessed at 12 months post-op as a composite outcome measure. This will be recorded as yes/no outcome and compared controls undergoing continuous NMP and SCS
Peak serum AST (U/L) 7 days The highest AST level recorded in the first 7 days post-transplant will be identified. This is a surrogate marker for longer-term outcome. It will be compared with matched controls of livers undergoing continuous NMP and SCS
Early allograft dysfunction (EAD) 7 days This is a composite score which is used to predict longer-term outcome. It comprises: bilirubin \>or=10mg/dL on day 7 post-transplant, international normalized ratio \>or=1.6 on day 7 post-transplant, and alanine or aspartate aminotransferases \>2000 IU/L within the first 7 days post-transplant. This will be compared with matched controls of livers undergoing continuous NMP and SCS
Trial Locations
- Locations (3)
King's College Hospital
🇬🇧London, United Kingdom
Royal Free Hospital
🇬🇧London, United Kingdom
Addenbrooke's Hospital
🇬🇧Cambridge, United Kingdom