End-stage Liver DiseasePhase 1NCT02478151
Using Ex-vivo Normothermic Machine Perfusion With the Organox Metra™ Device to Store Human Livers for Transplantation
A Phase 1 study testing OrganOx Metra in people with End-stage Liver Disease, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This trial will examine the safety and feasibility of using the OrganOx Metra device to transport and store donor livers under normothermic conditions prior to transplantation. Participants will be followed for 3 months following transplantation and their outcomes recorded. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- End-stage Liver Disease
- What is being tested?
- OrganOx Metra
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2015to 31 Mar 2023
- Phase
- Phase 1
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (18 years or more)
- Active on the waiting list for liver transplantation
- Able to give informed consent
Who cannot join
- 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
- Re-transplantation Diagnosis of Hepatopulmonary Syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Centre Study of the Feasibility and Safety of Using Ex-vivo Normothermic Machine Perfusion With the Organox Metra™ Device to Store Human Livers for Transplantation
This trial will examine the safety and feasibility of using the OrganOx Metra device to transport and store donor livers under normothermic conditions prior to transplantation. Participants will be followed for 3 months following transplantation and their outcomes recorded.
Read the detailed description
Liver transplantation is a life-saving procedure but its success has been limited by a shortage of suitable donor organs. Much emphasis is now placed on optimising the condition of those organs that are available, to enable more higher risk organs to be transplanted safely. An effective means of pre-transplant viability assessment would not only allow greater use of higher risk donors but also minimise the risk of primary non-function by identifying and excluding non-viable organs before subjecting a patient to the risk of surgery. Organ storage under normothermic perfusion conditions enables organ function to be evaluated prior to transplantation and further has been shown to prevent organ injury which is sustained during standard cold storage. This trial will examine the safety and feasibility of using the OrganOx Metra device to transport and store donor livers under normothermic conditions prior to transplantation. This study will evaluate liver function post-transplantation using standard clinical parameters. Participants will be followed for 3 months following transplantation and their outcomes recorded. Participants will undergo no other study procedures. Feasibility will be measured using the ratio of actual / eligible candidate donors recruited to the study and will also encompass logistical issues with respect to transportation, and ease of use. Safety will be assessed by rates of device failures resulting in organ discard, primary graft non-function, re-transplantation, and recipient death.
- Conditions
- End-stage Liver Disease
- Being tested
- OrganOx Metra
- Keywords
- Deceased donor liver transplant, Normothermic machine perfusion
- Medical subject headings
- End Stage Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrganOx MetraDevice
Normothermic machine perfusion (NMP) Metra device
| Study group | Role | What they receive |
|---|---|---|
| OrganOx Metra | Experimental | OrganOx Metra Device Receives: Device: OrganOx Metra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of primary graft non-function
Measured: 3 months
Rates of re-transplantation
Measured: 3 months
Rates of recipient death
Measured: 3 months
Secondary outcomes (11)
Rate of device failures resulting in organ discard
Measured: 3 months
Recruitment rates to the study
Measured by the ratio of actual / eligible candidate donors recruited to the study
Measured: 3 months
Ischemia- reperfusion injury associated with organ storage
Assessed by a post-perfusion biopsy
Measured: 7 days
Ischemia- reperfusion injury associated with organ storage
Assessed by measuring the peak serum aspartate transaminase level (AST) within 7 days post-transplant
Measured: 7 days
The function of liver grafts stored with the Metra™ device
Measured by bilirubin, alkaline phosphatase, AST and INR levels at days 1-7 post-transplant. The measure is a composite.
Measured: 3 months
The function of liver grafts stored with the Metra™ device
Measured by bilirubin, alkaline phosphatase, AST and INR levels at day 30 post-transplant. The measure is a composite.
Measured: 3 months
The function of liver grafts stored with the Metra™ device
Measured by bilirubin, alkaline phosphatase, AST and INR levels at month 3 post-transplant. The measure is a composite.
Measured: 3 months
The function of liver grafts stored with the Metra™ device
Measured by Lactate at days 1-3 post-transplant. The measure is a composite.
Measured: 3 months
The ability of perfusion parameters to predict clinical outcomes following transplantation
Perfusion flows and pressures will be studied to determine their correlation with graft injury and function. The measure is a composite.
Measured: 3 months
The ability of perfusion parameters to predict clinical outcomes following transplantation
Perfusate blood gas parameters will be studied to determine their correlation with graft injury and function. The measure is a composite.
Measured: 3 months
The ability of perfusion parameters to predict clinical outcomes following transplantation
Bile production will be studied to determine their correlation with graft injury and function
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2022 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Liver DiseaseStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David R Grant, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02478151
- Sponsor's protocol ID
- 14-8132-B
- Status last verified
- Apr 2022
- First submitted
- 1 Dec 2014
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Centre Study of the Feasibility and Safety of Using Ex-vivo Normothermic Machine Perfusion With the Organox Metra™ Device to Store Human Livers for Transplantation
- ClinicalTrials.gov ID
- NCT02478151
- Acronym / sponsor ID
- 14-8132-B
- Conditions
- End-stage Liver Disease
- Keywords
- Deceased donor liver transplant, Normothermic machine perfusion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 23 Jun 2015 (estimated)
- 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.
This trial will examine the safety and feasibility of using the OrganOx Metra device to transport and store donor livers under normothermic conditions prior to transplantation. Participants will be followed for 3 months following transplantation and their outcomes recorded.
Detailed description
Liver transplantation is a life-saving procedure but its success has been limited by a shortage of suitable donor organs. Much emphasis is now placed on optimising the condition of those organs that are available, to enable more higher risk organs to be transplanted safely. An effective means of pre-transplant viability assessment would not only allow greater use of higher risk donors but also minimise the risk of primary non-function by identifying and excluding non-viable organs before subjecting a patient to the risk of surgery. Organ storage under normothermic perfusion conditions enables organ function to be evaluated prior to transplantation and further has been shown to prevent organ injury which is sustained during standard cold storage. This trial will examine the safety and feasibility of using the OrganOx Metra device to transport and store donor livers under normothermic conditions prior to transplantation. This study will evaluate liver function post-transplantation using standard clinical parameters. Participants will be followed for 3 months following transplantation and their outcomes recorded. Participants will undergo no other study procedures. Feasibility will be measured using the ratio of actual / eligible candidate donors recruited to the study and will also encompass logistical issues with respect to transportation, and ease of use. Safety will be assessed by rates of device failures resulting in organ discard, primary graft non-function, re-transplantation, and recipient death.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OrganOx Metra | Experimental | Device: OrganOx MetraOrganOx Metra Device |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (18 years or more)
- Active on the waiting list for liver transplantation
- Able to give informed consent
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| OrganOx MetraNormothermic machine perfusion (NMP) Metra device | Device | OrganOx Metra |
Primary outcome
Rates of primary graft non-function
Time frame: 3 months
Rates of re-transplantation
Time frame: 3 months
Rates of recipient death
Time frame: 3 months
11 secondary outcomes
Rate of device failures resulting in organ discard
Time frame: 3 months
Recruitment rates to the study
Time frame: 3 months
Ischemia- reperfusion injury associated with organ storage
Time frame: 7 days
Ischemia- reperfusion injury associated with organ storage
Time frame: 7 days
The function of liver grafts stored with the Metra™ device
Time frame: 3 months
The function of liver grafts stored with the Metra™ device
Time frame: 3 months
The function of liver grafts stored with the Metra™ device
Time frame: 3 months
The function of liver grafts stored with the Metra™ device
Time frame: 3 months
The ability of perfusion parameters to predict clinical outcomes following transplantation
Time frame: 3 months
The ability of perfusion parameters to predict clinical outcomes following transplantation
Time frame: 3 months
The ability of perfusion parameters to predict clinical outcomes following transplantation
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
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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.
David R Grant, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OrganOx Metra in people with End-stage Liver Disease, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. 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 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of primary graft non-function (time frame: 3 months). The study lists 3 primary outcomes in all. 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 12 Apr 2022.