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Machine Perfusion

Hypothermic Oxygenated Perfusion for Liver Transplant

N/A

Waitlist Available

Led By David Reich, MD

Research Sponsored by Bridge to Life Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Anticipated cold ischemia time 10-15 hours (excluding HOPE duration)

Donor age 50-85 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year post-transplant

Awards & highlights

Study Summary

This trial will compare outcomes of liver transplants using two different methods of ex-vivo preservation.

Who is the study for?

This trial is for patients needing a liver transplant, where the donor's age is between 50-85 years. The donor liver must have been preserved in cold conditions for 10-15 hours and show certain levels of fat, enzymes (ALT), and bilirubin. It excludes livers not from brain-dead donors.Check my eligibility

What is being tested?

The study compares two ways to preserve donated livers before transplantation: traditional cold storage versus using the VitaSmart Liver Machine Perfusion System followed by hypothermic oxygenated perfusion (HOPE).See study design

What are the potential side effects?

Potential side effects are related to how well the transplanted liver functions after surgery, which can include complications like poor organ function or rejection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My surgery involves a cold ischemia time of 10-15 hours, not counting HOPE duration.

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I am between 50 and 85 years old.

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My total bilirubin level is between 2-4 mg/dl.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year post-transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year post-transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post-transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of patients with early allograft dysfunction (EAD)

Secondary outcome measures

Donor liver utilization rate

Duration on dialysis

Graft survival rate

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Static cold storageExperimental Treatment1 Intervention

Ex-vivo donor liver preservation using static cold storage only

Group II: Hypothermic oxygenated perfusion (HOPE)Experimental Treatment2 Interventions

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bridge to Life Ltd.Lead Sponsor

David Reich, MDPrincipal InvestigatorDrexel University

3 Previous Clinical Trials

20,406 Total Patients Enrolled

Media Library

VitaSmart Liver Machine Perfusion System (Machine Perfusion) Clinical Trial Eligibility Overview. Trial Name: NCT05045794 — N/A

Liver Disease Research Study Groups: Static cold storage, Hypothermic oxygenated perfusion (HOPE)

Liver Disease Clinical Trial 2023: VitaSmart Liver Machine Perfusion System Highlights & Side Effects. Trial Name: NCT05045794 — N/A

VitaSmart Liver Machine Perfusion System (Machine Perfusion) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05045794 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many medical facilities are actively administering this clinical trial?

"Patients may join this trial at Ochsner Clinic Foundation in New Orleans, Louisiana, Nebraska Medical Center in Omaha, Nebraska and Cleveland Clinic in Cleveland, Ohio as well as an additional 15 sites."

Answered by AI

How many participants have been recruited to take part in this research endeavor?

"Bridge to Life Ltd., the sponsor, will be conducting this clinical trial in multiple locations such as Ochsner Clinic Foundation and Nebraska Medical Center. They need a total of 244 eligible patients for it to commence."

Answered by AI

Is the enrollment for this trial still open?

"Affirmative. According to clinicaltrials.gov, this ongoing study is actively recruiting participants-- the trial was first posted on December 16th 2021 and last updated on September 20th 2022. The goal of the research is to enroll 244 patients across 15 different medical centres."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "Bridge to HOPE: Hypothermic Oxygenated Perfusion Versus Cold Storage Prior to Liver Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05045794.

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