Developing Viability Index for Machine Perfused Livers

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Heidi Yeh，Massachusetts General Hospital

Tracking Information

First Submitted Date ^ICMJE

September 26, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

October 1, 2018

Estimated Primary Completion Date

October 1, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Peak transaminase value post transplant[ Time Frame: 1 Year ]

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

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Acute Liver Rejection[ Time Frame: 1 Year ]
Incidence of major Infection[ Time Frame: 1 Year ]
Hepatitis C Recurrence (in Hepatitis C positive recipients)[ Time Frame: 1 Year ]
Kidney Failure[ Time Frame: 1 Year ]
Biliary Complications[ Time Frame: 1 Year ]
Liver Graft Failure[ Time Frame: 1 Year ]
Death[ Time Frame: 1 Year ]

Descriptive Information

Brief Title ^ICMJE

Developing Viability Index for Machine Perfused Livers

Official Title ^ICMJE

Development of a Liver Viability Index for Transplantation

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation:
Intervention Model: Single Group Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Diagnostic

Condition ^ICMJE

Intervention ^ICMJE

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.

Study Arms

Experimental: Biopsy
Biopsies taken at protocol specified time points

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

October 1, 2023

Estimated Primary Completion Date

October 1, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Heidi Yeh，Massachusetts General Hospital

Study Sponsor ^ICMJE

Massachusetts General Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Massachusetts General Hospital

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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