Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
| Shriners Hospitals for Children | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biopsy | Experimental | Biopsies taken at protocol specified time points |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liver Biopsy | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak transaminase value post transplant | The primary endpoint is peak transaminase values since transaminase elevation is a marker of hepatocyte injury | 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Liver Rejection | 1 Year | |
| Incidence of major Infection | 1 Year | |
| Hepatitis C Recurrence (in Hepatitis C positive recipients) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Heidi Yeh, MD | Contact | 617-726-3664 | hyeh@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Heidi Yeh, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 1 Year |
| Kidney Failure | 1 Year |
| Biliary Complications | 1 Year |
| Liver Graft Failure | 1 Year |
| Death | 1 Year |