Bridge to HOPE: Hypothermic Oxygenated Perfusion Versus Cold Storage Prior to Liver Transplantation

  • STATUS
    Recruiting
  • End date
    Nov 30, 2024
  • participants needed
    244
  • sponsor
    Bridge to Life Ltd.
Updated on 22 March 2022
carcinoma

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.

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.

Details
Condition End Stage Liver DIsease, Liver Failure
Treatment Static cold storage, VitaSmart Liver Machine Perfusion System
Clinical Study IdentifierNCT05045794
SponsorBridge to Life Ltd.
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Donor age 18-60 years
Anticipated cold ischemia time <12 hours (excluding HOPE duration)
Functional warm ischemia time ≤35 minutes, defined as interval from the time of onset of donor hypotension (MAP <50mmHg) until the time of donor cross clamp
Macrosteatosis ≤20%
Terminal ALT ≤500 IU/ml
Peak ALT within 3 days ≤2000 IU/ml
Terminal total bilirubin ≤3 mg/dl
Donation after Cardio-circulatory Death (DCD) Liver Exclusion Criteria (one or
more)
Presence of hemodynamic and/or anatomical donor abnormalities that, in the opinion of the Investigator, make the liver allograft unsuitable for transplant into the recipient subject
Liver intended for split transplant
Liver from living donor
Donor terminal serum Na >160 mmol/L
Recipient Inclusion Criteria (one or more)
Subject (or legally authorized representative) is able to provide informed consent and HIPAA authorization
Subject is male or female and at least 18 years of age
Subject is registered as an active liver recipient on the UNOS waiting list for liver transplantation
Subject will undergo primary liver transplantation
Subject is willing to comply with the study requirements and procedures
Subject with hepatocellular carcinoma as indication for Orthotopic Liver Transplantation; the tumor must be within Milan Criteria or down-staged to Milan Criteria

Exclusion Criteria

Subject will undergo multiple organ transplantations (liver-kidney, liver-lung, etc.)
Subject is listed for liver transplantation due to fulminant liver failure (UNOS status 1A)
Subject is pregnant
Subject is on respiratory (ventilator dependent) and/or cardiocirculatory support (requires at least one intravenous inotrope to maintain hemodynamics)
Subject is enrolled in an interventional clinical trial with an investigational drug or device
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