Comparison of Hypothermic Versus Normothermic Ex-vivo Preservation. (NCT04744389) | Clinical Trial Compass
UnknownNot Applicable
Comparison of Hypothermic Versus Normothermic Ex-vivo Preservation.
Italy60 participantsStarted 2020-12-15
Plain-language summary
Study groups:
The study is a multicenter (Pisa and Milan), prospective, randomized study comparing D-HOPE (HMP) vs NMP in DCD and ECD-DBD (extended criteria brain-dead donors). Once a DCD or a DBD with extended criteria (ECD-DBD) meets the inclusion criteria, they are randomized as follow:
1. 20 liver grafts from DCD after normothermic regional perfusion (NRP) matching the inclusion criteria are randomized 1:1 to hypothermic machine perfusion (HMP) vs normothermic machine perfusion (NMP) and then transplanted.
2. 40 liver grafts from ECD-DBD matching the inclusion criteria are randomized 1:1 to hypothermic machine perfusion (HMP) vs normothermic machine perfusion (NMP) and then transplanted
Who can participate
Age range
18 Years – 75 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.
GRAFT:
Inclusion criteria:
DCD:
* no absolute contraindications as per Italian National Transplant center (CNT)
* donor age ≤70 years
* witnessed and documented cardiac arrest
* macro-vescicular steatosis \<30% at liver biopsy
* necrosis \<5% at liver biopsy
* fibrosis \<2 as per Ishak's score at liver biopsy
* arteriolar thickening \<60% at liver biopsy
* WIT ≤160 minutes
* ALT \<1000 UI/L during NRP
* downward trend lactate during NRP
DBD:
* no absolute contraindications as per Italian National Transplant center (CNT)
* donor age \> 70 years
* macro-steatosis between 30 and 50% at liver biopsy
Exclusion criteria:
DCD:
* absolute contraindications as per Italian National Transplant center (CNT)
* donor age \>70 years
* macro-vescicular steatosis \>30% at liver biopsy
* necrosis \>5% at liver biopsy
* fibrosis \>2 as per Ishak's score at liver biopsy
* severe macroangiopathy (arteriolar thickening \>60% at liver biopsy)
* WIT \>160 minutes
* ALT \>1000 UI/L during NRP
* uptrend lactate during NRP
DBD:
* absolute contraindications as per Italian National Transplant center (CNT)
* donor age \< 70 years
* macro-steatosis between \> 50% at liver biopsy
RECIPIENTS
Inclusion criteria:
* Subject must be greater than or equal to 18 years of age.
* Subject with end-stage liver disease who is actively listed for primary liver transplantation
* Subject, or a legally authorized representative, has given informed consent to participate in the study
Exclusion criteria:
* Sub…
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.