Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Garrett Roll, MD

Description

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.

Official Title

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

Details

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.

Keywords

End Stage Liver DIsease Liver Failure Hypothermic oxygenated machine perfusion Liver preservation Liver transplantation Liver Diseases Liver Extracts VitaSmart Liver Machine Perfusion System Static cold storage Hypothermic oxygenated perfusion (HOPE)

Eligibility

For people ages 18 years and up

Donation after Brain Death (DBD) Liver Inclusion Criteria (one or more):

  • Donor age 50-85 years
  • Anticipated cold ischemia time 10-15 hours (excluding HOPE duration)
  • Macrosteatosis 10-40%
  • Terminal ALT 250-1500 IU/ml
  • Peak ALT within 3 days 1000-3000 IU/ml
  • Terminal total bilirubin 2-4 mg/dl

Donation after Brain Death (DBD) Liver Exclusion Criteria (one or more):

  • Donor age <18 or >85 years
  • Anticipated cold ischemia >15 hours
  • Macrosteatosis >40%
  • Terminal ALT >1500 IU/ml
  • Peak ALT within 3 days >3000 IU/ml
  • Terminal total bilirubin >4 mg/dl
  • 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

Donation after Cardio-circulatory Death (DCD) Liver Inclusion Criteria (all):

  • 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

Recipient Exclusion Criteria (one or more):

  • 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

Locations

  • University of California San Francisco
    San Francisco California 94143 United States
  • Loma Linda University Medical Center
    San Bernardino California 92408 United States

Lead Scientist at UCSF

  • Garrett Roll, MD
    Associate Professor, Surgery. Authored (or co-authored) 77 research publications.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Bridge to Life Ltd.
ID
NCT05045794
Study Type
Interventional
Last Updated