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End Stage Liver DIseaseNCT05045794

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

A study testing VitaSmart™Liver Machine Perfusion System and Static cold storage in people with End Stage Liver DIsease and Liver Failure, run by Bridge to Life Ltd. at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
End Stage Liver DIsease, Liver Failure
What is being tested?
VitaSmart™Liver Machine Perfusion System and Static cold storage
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
228 participants
Where
15 sitesUnited States
Study dates
16 Dec 2021to 31 May 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

United States15 sites

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01895

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • Indiana University

    Indianapolis, Indiana, 46202

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • University of Wisconsin Madison

    Madison, Wisconsin, 53792

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Mount Sinai Hospital

    New York, New York, 10029

  • Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Loma Linda University Medical Center

    San Bernadino, California, 92408

  • University of California San Francisco

    San Francisco, California, 94143

  • Washington University St. Louis

    St Louis, Missouri, 63110

  • Stanford University Medical Center

    Stanford, California, 94305

  • Cleveland Clinic

    Weston, Florida, 33331

Other trials in United States

About this study

Official title: Multicenter, Prospective, Open-label, Randomized Controlled Clinical Trial to Compare the Safety & Effectiveness of the VitaSmart Liver Machine Perfusion System With Static Cold Storage for Organ Preservation Prior to Liver Transplantation

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.

Read the 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.

Being tested
VitaSmart™Liver Machine Perfusion System, Static cold storage
Keywords
Hypothermic oxygenated machine perfusion, Liver preservation, Liver transplantation
Medical subject headings
End Stage Liver Disease, Liver Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VitaSmart™Liver Machine Perfusion SystemDevice

    Also called VitaSmart™ Liver Machine, Hypothermic oxygenated perfusion

    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.

  • Static cold storageOther

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

Study groups in NCT05045794
Study groupRoleWhat they receive
Hypothermic oxygenated perfusion (HOPE)ExperimentalEx-vivo donor liver preservation using static cold storage followed by HOPE using the VitaSmart™ Liver Machine
Receives: Device: VitaSmart™Liver Machine Perfusion System; Other: Static cold storage
Static Cold Storage (SCS)OtherEx-vivo donor liver preservation using static cold storage only
Receives: Other: Static cold storage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Early Allograft Dysfunction (EAD)

    Proportion of participants with EAD by 7 days post-transplant (or at hospital discharge if prior to 7 days). Defined by the presence of one or more of the following outcomes:

    • Serum bilirubin ≥10 mg/dL at day 7 post-transplant
    • INR ≥1.6 at day 7 post-transplant
    • ALT or AST >2000 IU/L within the first 7 days post-transplant

    Measured: 7 days

  2. Graft Survival at 6 Months

    Graft survival is defined as absence of death or graft failure

    Measured: 6 months following transplantation

  3. Participant Survival at 6 Months

    Participant survival is defined as absence of death.

    Measured: 6 months following transplantation

Secondary outcomes (11)

  1. Graft Survival at 12 Months/30 Days

    Graft survival is defined as absence of death or graft failure

    Measured: Up to 12 months following transplantation

  2. Participant Survival at 12 Months/30 Days

    Participant survival is defined as absence of death.

    Measured: Up to 12 months following transplantation

  3. Model for Early Allograft Function (MEAF) Score

    Model for Early Allograft Score (MEAF) is a continuous scoring system based on the subject's maximum labs within the first three days post transplant, alanine aminotransferase (ALT) and international normalized ratio (INR) plus day-3 bilirubin. The score ranges from 0-10 with 0 being the worst to 10 being the best and provides a grade for liver dysfunction severity.

    Measured: Within 3 days post-transplant

  4. Primary Non-function (PNF)

    Defined as early graft failure resulting in re-transplantation or death with no hepatic artery thrombosis or other detectible technical complications and with AST≥3000 IU/L and either INR≥2.5, arterial pH≤7.30, venous pH≤7.25 or serum lactate≥4mmol/L

    Measured: Within 7 days post-transplant

  5. Length of Hospital Stay

    Duration from initial ICU or floor admission to hospital discharge order (measured in days)

    Measured: End of surgery to hospital discharge

  6. Length of Intensive Care Unit Stay

    Duration from initial intensive care unit (ICU) admission to ICU discharge order (measured in days), patients that did not go to ICU were assumed '0' days

    Measured: End of surgery to ICU discharge

  7. Duration on Renal Replacement Therapy (RRT)

    Includes patient that required RRT within 2 weeks post-transplantation; duration from until discontinuation of dialysis for >2 weeks

    Measured: Post-transplantation until RRT discontinued for >2 weeks

  8. Donor Liver Utilization

    Defined as the proportion of randomized donor/recipients to transplanted recipients

    Measured: Randomization to transplantation

  9. Biopsy-proven Liver Rejection

    Rejections confirmed on biopsy were tabulated between the 2 groups.

    Measured: Up to 12 months following transplantation

  10. Central Radiologist Diagnosed Non-anastomotic Strictures (NAS)

    Non-anastomotic strictures (NAS) were diagnosed by the blinded, central radiologist on cholangiograms (ERCP, MRCP)

    Measured: Up to 12 months after transplantation

  11. Unanticipated Adverse Device Effects (UADEs)

    UADE is defined as an adverse event that is serious and device related. UADE reporting is only applicable to the HOPE arm.

    Measured: 12 months after transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2021
  2. Study start16 Dec 2021
  3. Primary completion19 May 2023
  4. Study completion31 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a randomized, controlled, open-label, sequential assignment, non-inferiority design comparing two treatment arms (HOPE, static cold storage)
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
228 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05045794
Sponsor's protocol ID
BTL-2020-01vs
Status last verified
Jul 2026
First submitted
31 Aug 2021
Last updated
22 Jul 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Reich DJ, Mao S, Satish S, Nassar A, Rizzari M, Al-Adra DP, DiNorcia J, Woloszyn J, Doyle MBM, Bohorquez H, Mihaylov P, Saharia A, Merani S, Wehrle CJ, Miller C, Axelrod D, Langnas A, Melcher ML, Akoad M, Ghobrial M, Kubal C, Roll G, Cohen A, Chapman WC, Pinna A, de Vera M, Florman S, Foley DP, Abouljoud M, Quintini C, Hashimoto K, Croome K, Taner CB, Schlegel A. Portal-Venous Hypothermic Oxygenated Perfusion for Liver Transplant: A Randomized Clinical Trial. JAMA Surg. 2026 Jul 1;161(7):691-702. doi: 10.1001/jamasurg.2026.1604.

    PubMed 42201712

  • 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.

    PubMed 37496117

Questions about this trial

What is this clinical trial studying?

A study testing VitaSmart™Liver Machine Perfusion System and Static cold storage in people with End Stage Liver DIsease and Liver Failure, run by Bridge to Life Ltd. at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Early Allograft Dysfunction (EAD) (time frame: 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05045794, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.

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