Bridge to HOPE: Hypothermic Oxygenated Perfusion Versus Cold Storage Prior to Liver Transplantation
- Conditions
- Liver FailureEnd Stage Liver DIsease
- Interventions
- Device: VitaSmart Liver Machine Perfusion SystemOther: Static cold storage
- Registration Number
- NCT05045794
- Lead Sponsor
- Bridge to Life Ltd.
- Brief Summary
This is a prospective, multi-center, controlled, randomized, pivotal study to evaluate the safety and effectiveness of the VitaSmart Liver Machine Perfusion System by comparing clinical outcomes in patients undergoing liver transplantation with ex-vivo liver preservation using static cold storage (SCS) followed by hypothermic oxygenated machine perfusion (HOPE) versus SCS only.
- Detailed Description
Patients on the UNOS waiting list for liver transplantation who have been consented, meet study eligibility criteria and are matched to a liver allograft from donation after brain death (DBD) or donation after circulatory death (DCD) that meet the extended risk eligibility criteria will be randomized 1:1 to SCS followed by HOPE (HOPE arm) or to SCS only (SCS arm). The objective of the study is to demonstrate the safety and effectiveness of the VitaSmart Liver Machine by comparing endpoints between the HOPE and SCS arms.
Following transplantation, patients will be monitored daily (labs, adverse events, medications/procedures) while inpatient, and then additionally on Days 14 and 30 and Months 3, 6 and 12. The primary efficacy endpoint of early allograft dysfunction (EAD) rate will be assessed between HOPE and control using a non-inferiority design. An interim analysis is planned after approximately 70% of patients have been completed primary endpoint data collection to assess for early study completion based on non-inferiority or superiority.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 219
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hypothermic oxygenated perfusion (HOPE) VitaSmart Liver Machine Perfusion System Ex-vivo donor liver preservation using static cold storage followed by HOPE using the VitaSmart Liver Machine Static cold storage Static cold storage Ex-vivo donor liver preservation using static cold storage only Hypothermic oxygenated perfusion (HOPE) Static cold storage Ex-vivo donor liver preservation using static cold storage followed by HOPE using the VitaSmart Liver Machine
- Primary Outcome Measures
Name Time Method Proportion of patients with early allograft dysfunction (EAD) At Day 7 post-transplant
- Secondary Outcome Measures
Name Time Method Incidence of biopsy-proven liver rejection 6 months, 1 year post-transplant Proportion of patients with primary non-function (PNF) Within 7 days post-transplant Based on definition by Pareja et al, 2015 (doi: 10.1002/lt.23990)
Length of hospital stay Up to study participation ends at 1-year follow-up Duration from initial ICU admission to hospital discharge order (measured in days)
Donor liver utilization rate Up to study participation ends at 1-year follow-up Model for early allograft function (MEAF) score Within 3 days post-transplant Based on definition by Olthoff et al, 2010 (doi: 10.1002/lt.22091)
Duration on dialysis Up to study participation ends at 1-year follow-up Duration from establishment of graft reperfusion until discontinuation of dialysis (measured in days)
Patient survival rate 30 days, 6 months, 1 year post-transplant Graft survival rate 30 days, 6 months, 1 year post-transplant Incidence of adverse events (AEs) 1 year post-transplant Incidence of unanticipated adverse device effects (UADEs) 1 year post-transplant Length of intensive care unit stay Up to study participation ends at 1-year follow-up Duration from initial ICU admission to ICU discharge order (measured in days)
Incidence of serious AEs (SAEs) 1 year post-transplant Incidence of ischemic cholangiopathy 6 months, 1 year post-transplant
Trial Locations
- Locations (15)
Loma Linda University Medical Center
🇺🇸San Bernardino, California, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Lahey Hospital and Medical Center
🇺🇸Burlington, Massachusetts, United States
Washington University St. Louis
🇺🇸Saint Louis, Missouri, United States
Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Mount Sinai Hospital
🇺🇸New York, New York, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
University of Wisconsin Madison
🇺🇸Madison, Wisconsin, United States
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States