NCT03694691

Developing Viability Index for Machine Perfused Livers

Development of a Liver Viability Index for Transplantation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Cirrhoses

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-10-01
• Primary completion: 2028-12-01
• Completion: 2030-06-01
• First posted: 2018-10-03
• Last updated: 2025-11-03

Locations

1 site across 1 country: United States