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

NCT05045794 | Completed DMC FDA Device

• 1 other identifier: BTL-2020-01vs
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 16

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.

Conditions

End Stage Liver DIsease; Liver Failure

Keywords

Hypothermic oxygenated machine perfusion; Liver preservation; Liver transplantation

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with early allograft dysfunction (EAD)

  At Day 7 post-transplant

Secondary Outcomes (13)

• Model for early allograft function (MEAF) score

  Within 3 days 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

• Length of intensive care unit stay

  Up to study participation ends at 1-year follow-up

• Duration on dialysis

  Up to study participation ends at 1-year follow-up

Study Arms (2)

Hypothermic oxygenated perfusion (HOPE)

EXPERIMENTAL

Ex-vivo donor liver preservation using static cold storage followed by HOPE using the VitaSmart Liver Machine

Device: VitaSmart Liver Machine Perfusion System; Other: Static cold storage

Static cold storage

OTHER

Ex-vivo donor liver preservation using static cold storage only

Other: Static cold storage

Interventions

VitaSmart Liver Machine Perfusion System DEVICE

Following donor liver retrieval, preservation using static cold storage, and back table preparation in the transplant center operating room, the organ will be flushed with Belzer UW Machine Perfusion Solution (MPS) and perfused through the cannulated portal vein using cold, actively oxygenated MPS that is circulated at low pressure for 90 minutes to 5 hours. After disconnection from the device, donor liver implantation and reperfusion will proceed in accordance with institutional care standards.

Also known as: VitaSmart Liver Machine, Hypothermic oxygenated perfusion

Hypothermic oxygenated perfusion (HOPE)

Static cold storage OTHER

Donor liver retrieval and preservation using standard of care cold storage methods

Hypothermic oxygenated perfusion (HOPE); Static cold storage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Bridge to Life Ltd.: lead

Study Sites (16)

Loma Linda University Medical Center

San Bernardino, California, 92408, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Cleveland Clinic

Weston, Florida, 33331, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01895, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Washington University St. Louis

St Louis, Missouri, 63110, United States

Location

Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

University of Wisconsin Madison

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

• Kim SC, Foley DP. Strategies to Improve the Utilization and Function of DCD Livers. Transplantation. 2024 Mar 1;108(3):625-633. doi: 10.1097/TP.0000000000004739. Epub 2023 Jul 27.

  PMID: 37496117 DERIVED

MeSH Terms

Conditions

End Stage Liver Disease; Liver Failure

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Officials

• David Reich, MD

  Drexel University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: A centralized radiologist who evaluates imaging (MRCP) for one of the secondary endpoints (ischemic cholangiopathy) will be blinded to treatment assignment. The study is otherwise open label.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a randomized, controlled, open-label, sequential assignment, non-inferiority design comparing two treatment arms (HOPE, static cold storage)

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 16, 2021
• Study Start: December 16, 2021
• Primary Completion: June 10, 2024
• Study Completion: June 10, 2024
• Last Updated: June 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)