Pilot Study to Assess Safety and Feasibility of Normothermic Machine Preservation In Human Liver Transplantation

Completed · Not applicable

Conditions studied: Liver Transplantation

In brief

Normothermic machine perfusion (NMP) preservation is a promising method to decrease the complication of marginal donor livers compared to cold storage (CS). The aim of this project is to assess safety and feasibility of NMP in human liver transplantation. This will be a single center prospective cohort pilot study. Thirty-two livers with acceptable quality for transplantation will be preserved with NMP in 2-18 hours and transplanted. The follow-up period will be 6 months post-transplantation. The outcome will be compared to 100 historical patients transplanted in our program in the past 5 years (liver preserved using CS) with matched characteristics on age, Model for End-Stage Liver Disease (MELD) score, preservation time, etc.

Key facts

Study ID

NCT02515708

Run by

Cristiano Quintini

People needed

25

Starts

2016-05-16

Expected to finish

2020-06-09

Last updated by the study team

2020-10-19

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• Donor Exclusion Criteria:
• Donor age <14 or >70 years
• Liver steatosis (on visual estimate or on liver biopsy) > 30%
• Donors with Grade 2-3 traumatic liver laceration
• Partial grafts (living donors and split liver donors)
• Liver in which the investigator is unwilling or unable (for logistical reasons) to perform normothermic machine perfusion (NMP) preservation
• Inability to NMP perfuse the liver within 4 hours after cross clamp

Where it is running

• Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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