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Developing Viability Index for Machine Perfused Livers

Primary Purpose

Liver Cirrhoses

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Liver Biopsy

About this trial

This is an interventional diagnostic trial for Liver Cirrhoses

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Seropositivity for HIV-1.

Sites / Locations

Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Biopsy

Arm Description

Biopsies taken at protocol specified time points

Outcomes

Primary Outcome Measures

Peak transaminase value post transplant

The primary endpoint is peak transaminase values since transaminase elevation is a marker of hepatocyte injury

Secondary Outcome Measures

Acute Liver Rejection

Incidence of major Infection

Hepatitis C Recurrence (in Hepatitis C positive recipients)

Kidney Failure

Biliary Complications

Liver Graft Failure

Death

Full Information

NCT ID

NCT03694691

First Posted

September 26, 2018

Last Updated

October 4, 2023

Sponsor

Massachusetts General Hospital

Collaborators

Shriners

1. Study Identification

Unique Protocol Identification Number

NCT03694691

Brief Title

Developing Viability Index for Machine Perfused Livers

Official Title

Development of a Liver Viability Index for Transplantation

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 1, 2018 (Actual)

Primary Completion Date

December 1, 2024 (Anticipated)

Study Completion Date

June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

Shriners

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Cirrhoses

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Biopsy

Arm Type

Experimental

Arm Description

Biopsies taken at protocol specified time points

Intervention Type

Diagnostic Test

Intervention Name(s)

Liver Biopsy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Peak transaminase value post transplant

Description

The primary endpoint is peak transaminase values since transaminase elevation is a marker of hepatocyte injury

Time Frame

1 Year

Secondary Outcome Measure Information:

Title

Acute Liver Rejection

Time Frame

1 Year

Title

Incidence of major Infection

Time Frame

1 Year

Title

Hepatitis C Recurrence (in Hepatitis C positive recipients)

Time Frame

1 Year

Title

Kidney Failure

Time Frame

1 Year

Title

Biliary Complications

Time Frame

1 Year

Title

Liver Graft Failure

Time Frame

1 Year

Title

Death

Time Frame

1 Year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female 18-75 years of age. Candidate for a deceased-donor liver allograft. Exclusion Criteria: Seropositivity for HIV-1.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Heidi Yeh, MD

Phone

617-726-3664

hyeh@mgh.harvard.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Heidi Yeh, MD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Heidi Yeh

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Developing Viability Index for Machine Perfused Livers

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