A Multicenter, Prospective, Open-label, Randomized Controlled Clinical Trial to Compare the Safety and Effectiveness of the VitaSmart Liver Machine Perfusion System With Static Cold Storage for Organ Preservation Prior to Liver Transplantation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- End Stage Liver DIsease
- Sponsor
- Bridge to Life Ltd.
- Enrollment
- 219
- Locations
- 15
- Primary Endpoint
- Proportion of patients with early allograft dysfunction (EAD)
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Proportion of patients with early allograft dysfunction (EAD)
Time Frame: At Day 7 post-transplant
Secondary Outcomes
- 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)
- Length of hospital stay(Up to study participation ends at 1-year follow-up)
- 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)
- Duration on dialysis(Up to study participation ends at 1-year follow-up)
- 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)
- Incidence of serious AEs (SAEs)(1 year post-transplant)
- Incidence of ischemic cholangiopathy(6 months, 1 year post-transplant)