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ACTIVE NOT RECRUITING

NCT04483102

RESTORE Declined Livers Study

Sponsor: Washington University School of Medicine

View on ClinicalTrials.gov

Summary

This is a prospective, non-randomized, clinical trial of discarded liver transplants that have received normothermic machine perfusion (NMP), compared with standard cold preservation liver transplants. 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. Liver transplant outcomes will be ascertained during 12 months post-transplantation. The results of the trial will be compared with those of contemporary comparison groups of patients who received the standard criteria donor liver transplantation.

Official title: A Prospective, Single-Center, Non-Randomized, Clinical Trial of Transplantation of Discarded Livers Using Normothermic Machine Perfusion (NMP)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2020-12-03

Completion Date

2025-12-31

Last Updated

2025-06-25

Healthy Volunteers

Conditions

Liver Diseases Surgery Transplant; 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.

PRE-NMP DECLINED LIVER ELIGIBILITY: Inclusion Criteria: * DCD donor aged 6 years or greater and liver weight between 1 kg and 3.4 kg, with functional warm ischemic time (defined as the period between the systolic blood pressure less than 60 mmHg to the time of commencing donor aortic perfusion) in DCD donors less than 40 minutes * DCD asystolic warm ischemia time (from heartbeat stopping to initiation of cold flush) less than 15 minutes * DBD donor aged 6 years or greater and liver weight between 1 kg and 3.4 kg, with less than 8 hours cold ischemia time and DCD livers with less than 7 hours cold ischemia time (defined as the interim from initiation of donor in vivo cold organ preservation to removal of the liver graft from cold storage) * 'Rapid Recovery' donors for liver procurement, meeting the above criteria * Suboptimal in situ flush Exclusion Criteria: * DBD or DCD donor less than 6 years old * DCD grafts with donor functional warm ischemic time (defined as the period between the systolic blood pressure less than 60 mmHg to the time of commencing donor aortic perfusion) greater than or equal to 40 minutes * DCD asystolic warm ischemia time (from heartbeat stopping to initiation of cold flush) greater than or equal to 15 minutes * DBD livers with cold ischemia time greater than or equal to 8 hours and DCD livers with greater than or equal to 7 hours cold ischemia time * Donor serum bilirubin greater than or equal to 5 mg/dL * Liver weight less than 1 kg or greater than or equal to 3.5 kg * Grafts from patients with HIV infection * Cirrhotic livers * Livers with bridging fibrosis LIVER TRANSPLANTATION - HUMAN Inclusion criteria: * Subject must be greater than or equal to 18 years of age. * Subject with end-stage liver disease who is actively listed for primary liver transplantation on the UNOS waiting list * Subject, or a legally authorized representative, has given informed consent to participate in the study * Subject has a frailty classification of "Mild frailty/No frailty (Robust)", based on the Liver Frailty Index (LFI), which has been assessed within 6 months prior to liver transplant OR Subject is able to perform \>350 m on a 6 minute walk test (6MWT) within 6 months prior to liver transplant. * In all cases, the "most recent" (and within 6 months prior to transplant) measurement of LFI or 6MWT will be used to determine eligibility. Exclusion criteria: * Subject is currently listed as a UNOS status 1A. * Subject is requiring oxygen therapy via ventilator/respiratory support. * Subject is planned to undergo simultaneous solid organ transplant. * Subject is pregnant at the time of transplant. * Subject MELD score 29 or higher * Subject receives re-transplantation of liver.

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States