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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Liver Preservation Method
Addenbrooke's Hospital
Cambridge, United Kingdom
RECRUITINGKing's College Hospital
London, United Kingdom
NOT_YET_RECRUITINGRoyal Free Hospital
London, United Kingdom
RECRUITINGPatient and Graft Survival
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.
Time frame: 30 days
Peak serum AST (U/L)
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
Time frame: 7 days
Early allograft dysfunction (EAD)
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
Time frame: 7 days
Primary non-function
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 SCS
Time frame: 10 days
Adverse events, transplantation and organ discard rates.
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
Time frame: 30 days
Biliary investigation or intervention
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
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Time frame: 6 months
Patient and Graft Survival
Patient survival after liver transplantation and liver graft survival will be assessed at 6 months post-op as a composite outcome measure. This will be recorded as yes/no outcome and compared controls undergoing continuous NMP and SCS
Time frame: 6 months
Patient and Graft Survival
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
Time frame: 12 months