Safety and Feasibility of Normothermic Machine Perfusion to Preserve and Evaluate Orphan Livers
Study Details
Study Description
Brief 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. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Normothermic Liver perfusion This group has the liver grafts preserved using the Normothermic Liver perfusion Device |
Device: Normothermic Liver perfusion
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
|
Outcome Measures
Primary Outcome Measures
- The rate of patient survival [30 days post-transplantation]
- The rate of primary non-function [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
Secondary Outcome Measures
- The rate of Early Allograft Dysfunction post-transplantation [7 days 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)
- graft survival [6 months post-transplantation]
The allograft will be considered lost if a patient has a liver re-transplant or in the event of patient death.
- peak aspartate aminotransferase (AST) in the first 7 days post-transplantation [in the first 7 days post-transplantation]
CLINICAL LABORATORY TEST
- peak Alanine Aminotransferase (ALT) in the first 7 days post-transplantation [in the first 7 days post-transplantation]
CLINICAL LABORATORY TEST
- peak bilirubin in the first 7 days post-transplantation [in the first 7 days post-transplantation]
CLINICAL LABORATORY TEST
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients undergoing primary liver transplantation
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Age 18-75 years at the time of transplantation
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Willingness and ability to comply with the study procedures
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Signed Informed Consent Form
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For patients with hepatocellular carcinoma as indication for Orthoptic Liver Transplantation (OLT), tumor must be within Milan Criteria or down-staged to Milan Criteria.
Exclusion Criteria:
Recipient Exclusion Criteria:
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History of prior solid organ transplantation
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Patient on a respiratory and/or cardiocirculatory support at the time of transplant
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MELD score >35
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HIV positive patient
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Patient with current severe systemic infection
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Multiorgan transplant
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
Sponsors and Collaborators
- The Cleveland Clinic
Investigators
- Principal Investigator: Cristiano Quintini, MD, The Cleveland Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Orphan liver