Liver TransplantationNCT02775162
WP01 - Normothermic Liver Preservation
A study testing Normothermic Machine Perfusion (NMP) in people with Liver Transplantation, run by OrganOx Ltd. at 15 sites in United States.
Trial summary
A multicenter randomized controlled trial to compare the efficacy of ex-vivo normothermic machine profusion with static cold storage in human 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 Perfusion (NMP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- 15 sitesUnited States
- Study dates
- 9 Oct 2016to 19 Feb 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Subject is 18 years of age or greater
- Subject is registered as an active recipient on the United Network for Organ Sharing (UNOS) waiting list for liver transplantation
- Subject, or legally authorized representative, is able and willing to give informed consent and HIPAA authorization
- Subject is able and willing to comply with all study requirements
Who cannot join
- Subject requiring all of the following at the time of transplantation: oxygen therapy, inotropic support, renal replacement therapy
- Subject has acute/fulminant liver failure
- Subject undergoing simultaneous transplantation of more than one organ
- Subject is pregnant or nursing
- Concurrent enrollment in another clinical trial. Subjects enrolled in clinical trials or registries where only measurements and/or samples are taken (NO TEST DEVICE or TEST DRUG USED) are allowed to participate.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
University of Michigan
Ann Arbor, Michigan, 48109
University of Maryland
Baltimore, Maryland, 21201
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Duke University
Durham, North Carolina, 27710
Indiana University
Indianapolis, Indiana, 46202
University of Southern California (USC)
Los Angeles, California, 90033
University of California - Los Angeles (UCLA)
Los Angeles, California, 90095
University of Wisconsin Madison
Madison, Wisconsin, 53792
University of Miami
Miami, Florida, 33136
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Ochsner
New Orleans, Louisiana, 70121
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic - Phoenix
Phoenix, Arizona, 85054
University of California-San Francisco (UCSF)
San Francisco, California, 94153
Washington University
St Louis, Missouri, 63110
About this study
Official title: A Multicenter Randomized Controlled Trial to Compare the Efficacy of Ex-vivo Normothermic Machine Perfusion With Static Cold Storage in Human Liver Transplantation
A multicenter randomized controlled trial to compare the efficacy of ex-vivo normothermic machine profusion with static cold storage in human liver transplantation.
- Conditions
- Liver Transplantation
- Being tested
- Normothermic Machine Perfusion (NMP), Standard of Care (Ice)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normothermic Machine Perfusion (NMP)Device
Also called OrganOx metra® device
Standard of Care (Ice)Other
| Study group | Role | What they receive |
|---|---|---|
| Normothermic Machine Perfusion (NMP) | Experimental | Following the routine retrieval procedure of the liver, it will be placed on the OrganOx metra for Normothermic Machine Perfusion (NMP) for transport per the Investigational Plan and the Instructions For Use. Receives: Device: Normothermic Machine Perfusion (NMP) |
| Standard of Care (Ice) | Other | Following the routine retrieval procedure of the liver, it will be placed in ice-cold perfusion solution within an ice box for transport as dictated by logistics and local policy. Receives: Other: Standard of Care (Ice) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Early Allograft Dysfunction (EAD)
EAD is a binary outcome defined by the presence of one of the following 3 outcomes:
- Serum bilirubin ≥ 10 mg/dL at day 7 post-transplant
- International normalized ratio (INR) ≥ 1.6 at day 7 post-transplant
- Alanine Aminotransferase (ALT) or Aspartate Transaminase (AST) > 2000 IU/L within the first 7 days post-transplant
Measured: 7 Days
Secondary outcomes (17)
Number of Participants With Primary Non-Function
Primary Non-Function is defined in this study as irreversible graft dysfunction requiring emergency liver replacement during the first 10 days after liver transplantation.
Measured: 10 Days
Number of Participants With Graft Survival
Measured: 6 Months
Number of Participants With Subject Survival
Measured: 6 Months
Number of Participants With Post-Reperfusion Syndrome
Post-Reperfusion Syndrome is defined in this study as a decrease in mean arterial pressure (MAP) of more than 30% from the baseline value for more than one minute during the first five minutes after reperfusion.
Measured: 1 Day
Measure Biochemical Liver Function Via Bilirubin
Measured: 6 Months
Measure Biochemical Liver Function Via Gamma-Glutamyl Transferase (GGT)
Measured: 6 Months
Measure Biochemical Liver Function Via Alanine Aminotransferase (ALT)
Measured: 6 Months
Measure Biochemical Liver Function Via Aspartate Transaminase (AST)
Measured: 6 Months
Measure Biochemical Liver Function Via Alkaline Phosphatase (ALP)
Measured: 6 Months
Measure Biochemical Liver Function Via International Normalized Ratio (INR)
The international normalized ratio (INR) is a laboratory measurement of how long it takes blood to form a clot. It is calculated using the following formula: INR = (PT [test] / PT [control])^ISI
INR = international normalized ratio PT [test] = tested prothrombin time PT [control] = control prothrombin time ISI = international sensitivity index
Measured: 6 Months
Measure Biochemical Liver Function Via Lactate
Measured: Days 1-7
Number of Participants With Evidence of Ischemia-Reperfusion Injury Via Comparison of Pre-Reperfusion Biopsies to Post-Reperfusion Biopsies
Overall Degree of Ischemia Reperfusion Injury (IRI) was categorized as:
- None/Minimal: None or Polymorphonuclear Leukocytes (PMNs) in sinusoidal zone 3 with rare hepatocellular necrosis
- Mild: Polymorphonuclear Leukocytes (PMNs) in sinusoidal zone 3 with ≥ 1 cluster of necrotic hepatocytes
- Moderate/Severe: Clusters of hepatocellular necrosis in > 50% of lobules or 60% of parenchyma or panlobular necrosis in > 1 lobule
Measured: 1 Day
Number of Participants With Biliary Investigations and Biliary Interventions
Measured: 6 Months
Number of Livers Randomized But Not Transplanted
Measured: 1 Day
Number of Livers That Did Not Experience a Safety Event
Number of livers that did not experience at least one of the following safety events:
- Early Allograft Dysfunction (EAD)
- Discard of a Retrieved Liver
- Primary Non-Function (PNF)
Measured: 10 Days
Assessment of the Health Economic Implications Via Length of ICU Stay and Length of Hospital Stay
Measured: 6 Months
Compare Quality of Life Via the EQ-5D-5L Quality of Life Questionnaire
The EQ-5D-5L Questionnaire is the standard layout for recording an adult person's current self-reported health state. It consists of a standard format for respondents to record their health state according to the EQ-5D-5L descriptive system and the EQ Visual Analog Scale (VAS). EQ-5D-5L index scores range from 0 to 1.0 on a scale where 0 = death and 1.0 = perfect health. EQ-5D-5L is the name of the instrument and is not an acronym.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study start9 Oct 2016
- Primary completion10 Feb 2020
- Study completion19 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- OrganOx Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- North American Science Associates Ltd.
- Responsible party
- Sponsor
- Investigators
- Stuart Knechtle, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02775162
- Sponsor's protocol ID
- WP01
- Status last verified
- Jul 2022
- First submitted
- 30 Mar 2016
- Last updated
- 29 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Kubal C, Mihaylov P, Holden J. Oncologic indications of liver transplantation and deceased donor liver allocation in the United States. Curr Opin Organ Transplant. 2021 Apr 1;26(2):168-175. doi: 10.1097/MOT.0000000000000866.
PubMed 33650998
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Trial to Compare the Efficacy of Ex-vivo Normothermic Machine Perfusion With Static Cold Storage in Human Liver Transplantation
- ClinicalTrials.gov ID
- NCT02775162
- Acronym / sponsor ID
- WP01
- Conditions
- Liver Transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- OrganOx Ltd.Industry (pharma, biotech, devices)
- Collaborators
- North American Science Associates Ltd.
- Study start
- 9 Oct 2016 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 19 Feb 2021 (actual)
- First posted
- 17 May 2016 (estimated)
- Results
- Posted 22 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter randomized controlled trial to compare the efficacy of ex-vivo normothermic machine profusion with static cold storage in human liver transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normothermic Machine Perfusion (NMP) | Experimental | Device: Normothermic Machine Perfusion (NMP)Following the routine retrieval procedure of the liver, it will be placed on the OrganOx metra for Normothermic Machine Perfusion (NMP) for transport per the Investigational Plan and the Instructions For Use. |
| Standard of Care (Ice) | Other | Other: Standard of Care (Ice)Following the routine retrieval procedure of the liver, it will be placed in ice-cold perfusion solution within an ice box for transport as dictated by logistics and local policy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is 18 years of age or greater
- Subject is registered as an active recipient on the United Network for Organ Sharing (UNOS) waiting list for liver transplantation
- Subject, or legally authorized representative, is able and willing to give informed consent and HIPAA authorization
- Subject is able and willing to comply with all study requirements
Key exclusion criteria (5 listed)
- Subject requiring all of the following at the time of transplantation: oxygen therapy, inotropic support, renal replacement therapy
- Subject has acute/fulminant liver failure
- Subject undergoing simultaneous transplantation of more than one organ
- Subject is pregnant or nursing
- Concurrent enrollment in another clinical trial. Subjects enrolled in clinical trials or registries where only measurements and/or samples are taken (NO TEST DEVICE or TEST DRUG USED) are allowed to participate.
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 Perfusion (NMP)Also: OrganOx metra® device | Device | Normothermic Machine Perfusion (NMP) |
| Standard of Care (Ice) | Other | Standard of Care (Ice) |
Primary outcome
Percentage of Participants With Early Allograft Dysfunction (EAD)
Time frame: 7 Days
EAD is a binary outcome defined by the presence of one of the following 3 outcomes: * Serum bilirubin ≥ 10 mg/dL at day 7 post-transplant * International normalized ratio (INR) ≥ 1.6 at day 7 post-transplant * Alanine Aminotransferase (ALT) or Aspartate Transaminase (AST) > 2000 IU/L within the first 7 days post-transplant
17 secondary outcomes
Number of Participants With Primary Non-Function
Time frame: 10 Days
Number of Participants With Graft Survival
Time frame: 6 Months
Number of Participants With Subject Survival
Time frame: 6 Months
Number of Participants With Post-Reperfusion Syndrome
Time frame: 1 Day
Measure Biochemical Liver Function Via Bilirubin
Time frame: 6 Months
Measure Biochemical Liver Function Via Gamma-Glutamyl Transferase (GGT)
Time frame: 6 Months
Measure Biochemical Liver Function Via Alanine Aminotransferase (ALT)
Time frame: 6 Months
Measure Biochemical Liver Function Via Aspartate Transaminase (AST)
Time frame: 6 Months
Measure Biochemical Liver Function Via Alkaline Phosphatase (ALP)
Time frame: 6 Months
Measure Biochemical Liver Function Via International Normalized Ratio (INR)
Time frame: 6 Months
Measure Biochemical Liver Function Via Lactate
Time frame: Days 1-7
Number of Participants With Evidence of Ischemia-Reperfusion Injury Via Comparison of Pre-Reperfusion Biopsies to Post-Reperfusion Biopsies
Time frame: 1 Day
Number of Participants With Biliary Investigations and Biliary Interventions
Time frame: 6 Months
Number of Livers Randomized But Not Transplanted
Time frame: 1 Day
Number of Livers That Did Not Experience a Safety Event
Time frame: 10 Days
Assessment of the Health Economic Implications Via Length of ICU Stay and Length of Hospital Stay
Time frame: 6 Months
Compare Quality of Life Via the EQ-5D-5L Quality of Life Questionnaire
Time frame: 6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33650998Kubal C, Mihaylov P, Holden J. Oncologic indications of liver transplantation and deceased donor liver allocation in the United States. Curr Opin Organ Transplant. 2021 Apr 1;26(2):168-175. doi: 10.1097/MOT.0000000000000866.
- Individual participant dataSharing planned: No
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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.
Stuart Knechtle, MD principal investigator
Duke University
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normothermic Machine Perfusion (NMP) in people with Liver Transplantation, run by OrganOx Ltd. at 15 sites in United States.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Early Allograft Dysfunction (EAD) (time frame: 7 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02775162, which also lists 1 linked publication.
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 29 Jul 2022; AzTrials last refreshed its copy on 28 Oct 2026.