RESTORE Declined Livers Study

NAActive, not recruitingINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

December 3, 2020

Primary Completion Date

May 14, 2025

Study Completion Date

December 31, 2025

Conditions
Liver DiseasesSurgeryTransplant; Failure, Liver
Interventions
DEVICE

Declined liver in Normothermic Machine Perfusion (NMP)

The discarded livers rejected by all other centers and meeting pre-NMP eligibility criteria will receive NMP using the OrganOx® metra device. The NMP-treated liver that meets the viability criteria will be transplanted to patients who are eligible and consented to the study.

PROCEDURE

Standard cold preservation of liver

"The study will have three comparison groups - one local comparison group and two comparison groups from the national UNOS data.~Comparison group 1 will be patients who received a standard liver transplantation and follow-up care at the Washington University/ Barnes Jewish Hospital (n=50). Patients will be matched by a 5-year age category, sex, MELD score, donor liver graft type (e.g., DCD, DBD), donor age (5-year category), and donor sex. Washington University/ Barnes Jewish Hospital maintains a liver transplantation database that prospectively collects pre- and post-transplantation patient data.~Comparison group 2 will be patients who received DBD liver transplantation in the OPTN/UNOS database (n=100). Patients will be matched by age, sex, MELD score, donor age, and donor sex.~Comparison group 3 will be patients who received DCD liver transplantation in the OPTN/UNOS database (n=100). Patients will be matched by age, sex, MELD score, donor age, and donor sex."

Trial Locations (1)

63110

Washington University School of Medicine, St Louis

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Mid-America Transplant

OTHER

collaborator

OrganOx Ltd.

INDUSTRY

lead

Washington University School of Medicine

OTHER

NCT04483102 - RESTORE Declined Livers Study | Biotech Hunter | Biotech Hunter