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
1 other identifier
interventional
30
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started May 2017
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2017
CompletedFirst Submitted
Initial submission to the registry
May 4, 2017
CompletedFirst Posted
Study publicly available on registry
June 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2018
CompletedJune 5, 2017
June 1, 2017
3 months
May 4, 2017
June 1, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Peak serum AST (U/L)
7 days
Early allograft dysfunction (EAD)
7 days
Primary non-function
10 days
Adverse events, transplantation and organ discard rates.
30 days
Biliary investigation or intervention
6 months
- +2 more secondary outcomes
Interventions
Liver Preservation Method
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- Adult patients (18 years or more).
- Active on the waiting list for liver transplantation.
- Able to give informed consent.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Addenbrooke's Hospital
Cambridge, United Kingdom
King's College Hospital
London, United Kingdom
Royal Free Hospital
London, United Kingdom
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Friend
University of Oxford
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2017
First Posted
June 5, 2017
Study Start
May 1, 2017
Primary Completion
July 31, 2017
Study Completion
July 31, 2018
Last Updated
June 5, 2017
Record last verified: 2017-06