Post Static Cold Storage Normothermic Machine Liver Perfusion

Liver Transplantation Clinical Trial

Official title:

A Multicentre, Single-arm, Prospective Clinical Trial to Investigate the Safety and Feasibility of Cold Storage Prior to Normothermic Machine Perfusion in Adult Human Liver Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03176433
• Other study ID #: 16/LO/2196
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: May 4, 2017
• Last updated: June 1, 2017
• Start date: May 1, 2017
• Est. completion date: July 31, 2018

Study information

• Verified date: June 2017
• Source: University of Oxford
• Contact: Carlo DL Ceresa
• Phone: 00447776362098
• Email: carlo.ceresa[@]nds.ox.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 31, 2018
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Donor Inclusion Criteria:

• 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 Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Device:
• Normothermic Machine Liver Perfusion
Liver Preservation Method

Locations

Country	Name	City	State
United Kingdom	Addenbrooke's Hospital	Cambridge
United Kingdom	King's College Hospital	London
United Kingdom	Royal Free Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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	7 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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