Liver TransplantationNCT03456284
Safety and Feasibility of Normothermic Machine Perfusion to Preserve and Evaluate Orphan Livers
A study testing Normothermic Liver perfusion in people with Liver Transplantation, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Orphan livers are organs that have been declined for clinical use by all centers due to their marginality. The current standard of care of liver preservation before transplant is cold storage. NMP may allow these livers to be evaluated before transplantation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- Normothermic Liver perfusion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2020to Dec 2023
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing primary liver transplantation
- Age 18-75 years at the time of transplantation
- Willingness and ability to comply with the study procedures
- Signed Informed Consent Form
- For patients with hepatocellular carcinoma as indication for Orthoptic Liver Transplantation (OLT), tumor must be within Milan Criteria or down-staged to Milan Criteria.
Who cannot join
- Recipient Exclusion Criteria:
- History of prior solid organ transplantation
- Patient on a respiratory and/or cardiocirculatory support at the time of transplant
- MELD score >35
- HIV positive patient
- Patient with current severe systemic infection
- Multiorgan transplant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study to Assess Safety and Feasibility of Normothermic Machine Perfusion to Preserve and Evaluate Orphan Livers
Orphan livers are organs that have been declined for clinical use by all centers due to their marginality. The current standard of care of liver preservation before transplant is cold storage. NMP may allow these livers to be evaluated before transplantation. NMP has already been used in a clinical setting with promising results. The advantage to utilizing NMP is that it would attenuate the incidence and clinical impact of classical preservation injury, allow liver function assessment before implantation and thus improve donor pool and outcomes for high risk ECD liver transplants performed at our center.
Read the detailed description
This will be a single center prospective cohort pilot study. 30 livers that have been declined for clinical use by all centers due to their marginality will be preserved with NMP in 1-18 hours after cross clamp and cold flush. The liver grafts at NMP will be at Physiological temperature and have oxygen and nutrient supply with continuous perfusion. Once the liver grafts have been evaluated and determined to be transplantable, the transplantation and post-transplant care will follow the standard of care. The follow-up period is 12 months after transplantation. The primary end point will be the rate of patient survival and primary non function (PNF) within 30 days after transplantation, while the secondary end points will be: Early Allograft Dysfunction (EAD), 6 months patient and graft survival, peak liver function tests in the first 7 days after transplantation, surgical outcomes (operative time, transfusion requirement etc.), rate of post-transplant kidney failure, assessment of histological ischemia reperfusion (liver and bile duct), rate of vascular complications, rate of biliary complications, hospital and ICU length of stay, rejection rate, infection rate, the ability to predict function based on "on-pump" viability markers, and the incidence of adverse effect (AE).
- Conditions
- Liver Transplantation
- Being tested
- Normothermic Liver perfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normothermic Liver perfusionDevice
The liver grafts will be preserved and evaluated at physiological temperature and have continuous perfusion with oxygen and nutrient supply in the ex vivo organ preservation phase
| Study group | Role | What they receive |
|---|---|---|
| Normothermic Liver perfusion | Experimental | This group has the liver grafts preserved using the Normothermic Liver perfusion Device Receives: Device: Normothermic Liver perfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of patient survival
Measured: 30 days post-transplantation
The rate of primary non-function
primary non-function is defined as non life sustaining liver function requiring retransplantation or leading to death with 30 days after transplantation
Measured: 30 days post-transplantation
Secondary outcomes (5)
The rate of Early Allograft Dysfunction post-transplantation
The presence of at least one of the following at post-transplant 7 days: serum bilirubin >= 10 mg/dL, international normalized ratio (INF) >= 1.6; and/or aspartate aminotransferase (AST) > 2000 U/L at any time in the first 7 posttransplant days (POD)
Measured: 7 days post-transplantation
graft survival
The allograft will be considered lost if a patient has a liver re-transplant or in the event of patient death.
Measured: 6 months post-transplantation
peak aspartate aminotransferase (AST) in the first 7 days post-transplantation
CLINICAL LABORATORY TEST
Measured: in the first 7 days post-transplantation
peak Alanine Aminotransferase (ALT) in the first 7 days post-transplantation
CLINICAL LABORATORY TEST
Measured: in the first 7 days post-transplantation
peak bilirubin in the first 7 days post-transplantation
CLINICAL LABORATORY TEST
Measured: in the first 7 days post-transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start12 Mar 2020
- Primary completionJun 2023 (estimated)
- Study completionDec 2023 (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 The Cleveland ClinicThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Koji Hashimoto, The Cleveland Clinic
- Investigators
- Koji Hashimoto, MD, PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03456284
- Sponsor's protocol ID
- Orphan liver
- Status last verified
- Apr 2023
- First submitted
- 15 Feb 2018
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Assess Safety and Feasibility of Normothermic Machine Perfusion to Preserve and Evaluate Orphan Livers
- ClinicalTrials.gov ID
- NCT03456284
- Acronym / sponsor ID
- Orphan liver
- Conditions
- Liver Transplantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 12 Mar 2020 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 7 Mar 2018 (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.
Orphan livers are organs that have been declined for clinical use by all centers due to their marginality. The current standard of care of liver preservation before transplant is cold storage. NMP may allow these livers to be evaluated before transplantation. NMP has already been used in a clinical setting with promising results. The advantage to utilizing NMP is that it would attenuate the incidence and clinical impact of classical preservation injury, allow liver function assessment before implantation and thus improve donor pool and outcomes for high risk ECD liver transplants performed at our center.
Detailed description
This will be a single center prospective cohort pilot study. 30 livers that have been declined for clinical use by all centers due to their marginality will be preserved with NMP in 1-18 hours after cross clamp and cold flush. The liver grafts at NMP will be at Physiological temperature and have oxygen and nutrient supply with continuous perfusion. Once the liver grafts have been evaluated and determined to be transplantable, the transplantation and post-transplant care will follow the standard of care. The follow-up period is 12 months after transplantation. The primary end point will be the rate of patient survival and primary non function (PNF) within 30 days after transplantation, while the secondary end points will be: Early Allograft Dysfunction (EAD), 6 months patient and graft survival, peak liver function tests in the first 7 days after transplantation, surgical outcomes (operative time, transfusion requirement etc.), rate of post-transplant kidney failure, assessment of histological ischemia reperfusion (liver and bile duct), rate of vascular complications, rate of biliary complications, hospital and ICU length of stay, rejection rate, infection rate, the ability to predict function based on "on-pump" viability markers, and the incidence of adverse effect (AE).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normothermic Liver perfusion | Experimental | Device: Normothermic Liver perfusionThis group has the liver grafts preserved using the Normothermic Liver perfusion Device |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients undergoing primary liver transplantation
- Age 18-75 years at the time of transplantation
- Willingness and ability to comply with the study procedures
- Signed Informed Consent Form
- For patients with hepatocellular carcinoma as indication for Orthoptic Liver Transplantation (OLT), tumor must be within Milan Criteria or down-staged to Milan Criteria.
Key exclusion criteria (7 listed)
- History of prior solid organ transplantation
- Patient on a respiratory and/or cardiocirculatory support at the time of transplant
- MELD score >35
- HIV positive patient
- Patient with current severe systemic infection
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 Liver perfusionThe liver grafts will be preserved and evaluated at physiological temperature and have continuous perfusion with oxygen and nutrient supply in the ex vivo organ preservation phase | Device | Normothermic Liver perfusion |
Primary outcome
The rate of patient survival
Time frame: 30 days post-transplantation
The rate of primary non-function
Time frame: 30 days post-transplantation
primary non-function is defined as non life sustaining liver function requiring retransplantation or leading to death with 30 days after transplantation
5 secondary outcomes
The rate of Early Allograft Dysfunction post-transplantation
Time frame: 7 days post-transplantation
graft survival
Time frame: 6 months post-transplantation
peak aspartate aminotransferase (AST) in the first 7 days post-transplantation
Time frame: in the first 7 days post-transplantation
peak Alanine Aminotransferase (ALT) in the first 7 days post-transplantation
Time frame: in the first 7 days post-transplantation
peak bilirubin in the first 7 days post-transplantation
Time frame: in the first 7 days post-transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- 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.
Koji Hashimoto, MD, PhD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normothermic Liver perfusion in people with Liver Transplantation, run by The Cleveland Clinic at 1 site 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 5 inclusion and 7 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 13 Apr 2023. 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 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?
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?
The rate of patient survival (time frame: 30 days post-transplantation). The study lists 2 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 13 Apr 2023.