Developing Viability Index for Machine Perfused Livers

Liver Cirrhoses Clinical Trial

Official title:

Development of a Liver Viability Index for Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03694691
• Other study ID #: Liver Perfusion ATP
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: June 1, 2025

Study information

• Verified date: October 2023
• Source: Massachusetts General Hospital
• Contact: Heidi Yeh, MD
• Phone: 617-726-3664
• Email: hyeh[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Machine perfusion technology is nearing the point of rescuing discarded liver grafts in the hope of proving them to be or improving them to the point of being transplantable. However, there are no validated metrics to determine transplantability after machine perfusion. This study involves collecting biopsies from transplanted livers before and after implantation to correlate metabolite and gene expression with post-transplant function. This data will help develop a viability index for machine perfused livers.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Male or female 18-75 years of age.
• Candidate for a deceased-donor liver allograft.

Exclusion Criteria:

• Seropositivity for HIV-1.

Related Conditions & MeSH terms

• Liver Cirrhoses
• Liver Cirrhosis

Intervention

Diagnostic Test:
• Liver Biopsy
For measurement of tissue co-factor levels, we will take needle biopsies of transplanted livers immediately after procurement, immediately prior to implantation (at the end of preservation), 30 minutes after portal vein reperfusion, and 30 minutes after hepatic artery reperfusion. For those livers that have more than 60 minutes between portal vein and hepatic artery reperfusion, an additional biopsy will be performed at 60 minutes after portal vein reperfusion. Post-procurement biopsies will be collected regardless of where the liver was obtained.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Shriners

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak transaminase value post transplant	The primary endpoint is peak transaminase values since transaminase elevation is a marker of hepatocyte injury	1 Year
Secondary	Acute Liver Rejection		1 Year
Secondary	Incidence of major Infection		1 Year
Secondary	Hepatitis C Recurrence (in Hepatitis C positive recipients)		1 Year
Secondary	Kidney Failure		1 Year
Secondary	Biliary Complications		1 Year
Secondary	Liver Graft Failure		1 Year
Secondary	Death		1 Year