Liver TransplantationPhase 1/2NCT03176433
Post Static Cold Storage Normothermic Machine Liver Perfusion
A Phase 1/2 study testing Normothermic Machine Liver Perfusion in people with Liver Transplantation, run by University of Oxford at 3 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- Normothermic Machine Liver Perfusion
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 1 May 2017to 31 Jul 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites, 3 recruiting
- Recruiting
Addenbrooke's Hospital
Cambridge
Christopher Watson
- Not yet recruiting
King's College Hospital
London
Wayel Jassem
- Recruiting
Royal Free Hospital
London
Charles Imber
About this study
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
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.
- Conditions
- Liver Transplantation
- Being tested
- Normothermic Machine Liver Perfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normothermic Machine Liver PerfusionDevice
Liver Preservation Method
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (7)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start1 May 2017
- Primary completion31 Jul 2017 (estimated)
- Study completion31 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Friend, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03176433
- Sponsor's protocol ID
- 16/LO/2196
- Status last verified
- Jun 2017
- First submitted
- 4 May 2017
- Last updated
- 5 Jun 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03176433
- Acronym / sponsor ID
- 16/LO/2196
- Conditions
- Liver Transplantation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Jul 2017 (estimated)
- Study completion
- 31 Jul 2018 (estimated)
- First posted
- 5 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normothermic Machine Liver PerfusionLiver Preservation Method | Device | – |
Primary outcome
Patient and Graft Survival
Time frame: 30 days
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.
7 secondary outcomes
Peak serum AST (U/L)
Time frame: 7 days
Early allograft dysfunction (EAD)
Time frame: 7 days
Primary non-function
Time frame: 10 days
Adverse events, transplantation and organ discard rates.
Time frame: 30 days
Biliary investigation or intervention
Time frame: 6 months
Patient and Graft Survival
Time frame: 6 months
Patient and Graft Survival
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Friend principal investigator
University of Oxford
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Normothermic Machine Liver Perfusion in people with Liver Transplantation, run by University of Oxford at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlo DL Ceresa (00447776362098, carlo.ceresa@nds.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient and Graft Survival (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2017.