Safety and Feasibility of Normothermic Machine Perfusion to Preserve and Evaluate Orphan Livers

NCT03456284 | Unknown DMC FDA Device

• 1 other identifier: Orphan liver
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Transplantation

Outcome Measures

Primary Outcomes (2)

• The rate of patient survival

  30 days post-transplantation

• The rate of primary non-function

  primary non-function is defined as non life sustaining liver function requiring retransplantation or leading to death with 30 days after transplantation

  30 days post-transplantation

Secondary Outcomes (5)

• The rate of Early Allograft Dysfunction post-transplantation

  7 days post-transplantation

• graft survival

  6 months post-transplantation

• peak aspartate aminotransferase (AST) in the first 7 days post-transplantation

  in the first 7 days post-transplantation

• peak Alanine Aminotransferase (ALT) in the first 7 days post-transplantation

  in the first 7 days post-transplantation

• peak bilirubin in the first 7 days post-transplantation

  in the first 7 days post-transplantation

Study Arms (1)

Normothermic Liver perfusion

EXPERIMENTAL

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

Device: Normothermic Liver perfusion

Interventions

Normothermic Liver perfusion DEVICE

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

Normothermic Liver perfusion

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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Study Officials

• Koji Hashimoto, MD, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: February 15, 2018
• First Posted: March 7, 2018
• Study Start: March 12, 2020
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 13, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)