Bridge to HOPE: Hypothermic Oxygenated Perfusion Versus Cold Storage Prior to Liver Transplantation (NCT05045794) | Clinical Trial Compass
CompletedNot Applicable
Bridge to HOPE: Hypothermic Oxygenated Perfusion Versus Cold Storage Prior to Liver Transplantation
United States228 participantsStarted 2021-12-16
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 Invest…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.