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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normothermic Machine Liver Perfusion | Device | Liver Preservation Method |
| Measure | Description | Time Frame |
|---|---|---|
| Patient 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. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 7 days |
| Early allograft dysfunction (EAD) |
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Donor Inclusion Criteria:
Donor Exclusion Criteria:
Recipient Inclusion Criteria:
Recipient Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carlo DL Ceresa | Contact | 00447776362098 | carlo.ceresa@nds.ox.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Peter Friend | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Addenbrooke's Hospital | Recruiting | Cambridge | United Kingdom |
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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 |
| 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 | 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 | 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 | 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 | 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 | 12 months |
| King's College Hospital | Not yet recruiting | London | United Kingdom |
|
| Royal Free Hospital | Recruiting | London | United Kingdom |
|