Post Static Cold Storage Normothermic Machine Liver Perfusion

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

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 Overview

• Status: Unknown
• Conditions: Liver Transplantation
• Intervention / Treatment: Device: Normothermic Machine Liver Perfusion

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Cambridge, United Kingdom
    • Recruiting
    • Addenbrooke's Hospital
    • Contact: Christopher Watson
  • London, United Kingdom
    • Not yet recruiting
    • King's College Hospital
    • Contact: Wayel Jassem
  • London, United Kingdom
    • Recruiting
    • Royal Free Hospital
    • Contact: Charles Imber

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: University of Oxford
• Investigators: Principal Investigator: Peter Friend, University of Oxford

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Anticipated): July 31, 2017
• Study Completion (Anticipated): July 31, 2018

Study Registration Dates

• First Submitted: May 4, 2017
• First Submitted That Met QC Criteria: June 1, 2017
• First Posted (Actual): June 5, 2017

Study Record Updates

• Last Update Posted (Actual): June 5, 2017
• Last Update Submitted That Met QC Criteria: June 1, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 16/LO/2196

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No