Hypothermic Machine Perfusion for Liver Graft Preservation
Brazil40 participantsStarted 2026-05-07
Plain-language summary
The goal of this clinical trial is to evaluate whether hypothermic machine perfusion improves liver graft preservation and post-transplant outcomes compared to conventional static cold storage in adult patients undergoing liver transplantation. This study focuses on liver grafts from deceased donors, including those with extended criteria, which are more susceptible to ischemia-reperfusion injury and early graft dysfunction.
The main questions it aims to answer are:
Does hypothermic machine perfusion reduce ischemia-reperfusion injury and improve early graft function after liver transplantation? Does this preservation strategy improve clinical outcomes, including graft survival, complication rates, and post-transplant recovery, compared to static cold storage?
Researchers will compare hypothermic machine perfusion (ex situ, oxygenated perfusion at low temperature) to standard static cold storage to assess differences in graft preservation quality and post-transplant outcomes.
Participants will:
Receive a liver graft preserved either by hypothermic machine perfusion or static cold storage, according to a 1:1 randomization protocol Undergo standard liver transplantation procedures Be followed after transplantation with clinical, laboratory, imaging, and biomarker assessments at predefined time points (7 days, 30 days, 6 months, and 1 year)
Additional evaluations will include biochemical markers of liver function, inflammatory and immunological mediators, mitochondrial function assessment, and histological analysis to better characterize graft injury and recovery.
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.
Donor-related inclusion criteria:
* Liver donors with confirmed diagnosis of brain death.
* Extended criteria donors (ECD).
* Age ≥18 years.
* Family consent for organ donation obtained.
* Negative serology for HTLV, HIV, Chagas disease, and hepatitis B and C.
Recipient-related inclusion criteria:
* Adult patients (≥18 years) undergoing liver transplantation.
* Diagnosis of end-stage liver disease or indication for liver transplantation.
* Candidates for primary liver transplantation.
* Ability to understand and provide written informed consen
Donor-related exclusion criteria:
* Presence of moderate or severe hepatic steatosis.
* Pediatric donors.
* Donors classified as ideal, defined by the simultaneous presence of all of the following criteria: Age \<35 years, Body mass index (BMI) \<28 kg/m², No history of cardiopulmonary resuscitation, Norepinephrine requirement \<0.5 µg/kg/min, Liver enzymes (AST or ALT) ≥2 times the upper limit of normal, Intensive care unit stay ≤7 days
Recipient-related exclusion criteria:
* Complex portal vein thrombosis (grade III or IV).
* Combined or dual organ transplantation.
* Retransplantation.
* Acute liver failure.
* MELD score \>30.
* History of multiple prior liver or biliary surgeries.
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.