Clinical trial NCT03456284: Safety and Feasibility of Normothermic Machine Perfusion to Preserve and Evaluate Orphan Livers
Official title: Pilot Study to Assess Safety and Feasibility of Normothermic Machine Perfusion to Preserve and Evaluate Orphan Livers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Transplantation
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2018-03-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: The rate of patient survival
timeFrame: 30 days post-transplantation
measure: The rate of primary non-function
timeFrame: 30 days post-transplantation
Secondary outcomes:
measure: The rate of Early Allograft Dysfunction post-transplantation
timeFrame: 7 days post-transplantation
measure: graft survival
timeFrame: 6 months post-transplantation
measure: peak aspartate aminotransferase (AST) in the first 7 days post-transplantation
timeFrame: in the first 7 days post-transplantation
measure: peak Alanine Aminotransferase (ALT) in the first 7 days post-transplantation
timeFrame: in the first 7 days post-transplantation
measure: peak bilirubin in the first 7 days post-transplantation
timeFrame: in the first 7 days post-transplantation
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Koji Hashimoto, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: