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

NCT02515708 | Completed DMC FDA Device

• 1 other identifier: 15-549
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• the rate of Early Allograft Dysfunction post-transplantation in Normothermically Machine Perfused (NMP) livers

  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 post-transplant days (POD)

  7 days post-transplantation

Secondary Outcomes (15)

• primary non-function rate

  in the first 10 days post-transplantation

• graft survival

  6 months post-transplantation

• peak liver function tests in the first 7 days post-transplantation

  in the first 7 days post-transplantation

• intraoperative flow measurement

  intraoperative

• post reperfusion syndrome (composite)

  in the first 7 days post-transplantation

Study Arms (2)

Normothermic Liver perfusion

EXPERIMENTAL

This group has the liver grafts preserved using the Normothermic Liver perfusion Device.

Device: Normothermic Liver perfusion Device

Normothermic Machine Perfusion (single pump)

OTHER

This group has the liver grafts preserved using a single-pump variant of the Normothermic Liver perfusion Device.

Device: Normothermic Liver perfusion Device

Interventions

Normothermic Liver perfusion Device 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.

Normothermic Liver perfusion; Normothermic Machine Perfusion (single pump)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

• 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 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

Sponsors & Collaborators

• Cristiano Quintini: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Study Officials

• Cristiano Quintini, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: July 30, 2015
• First Posted: August 5, 2015
• Study Start: May 16, 2016
• Primary Completion: June 9, 2020
• Study Completion: June 9, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)