MedTrace Logo

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

NCT02515708 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2020-10-19

No results posted yet for this study

Summary

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.

Conditions

  • Liver Transplantation

Interventions

DEVICE

Normothermic Liver perfusion Device

The liver grafts will be preserved at physiological temperature and have continuous perfusion with oxygen and nutrient supply in the ex vivo organ preservation phase.

Sponsors & Collaborators

  • Cristiano Quintini

    lead OTHER

Principal Investigators

  • Cristiano Quintini, MD · The Cleveland Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-16
Primary Completion
2020-06-09
Completion
2020-06-09
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02515708 on ClinicalTrials.gov