Machine Perfusion for Liver Transplant Preservation
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to preserve donor livers for transplant using a special machine. It combines cooling (hypothermic) and warming (normothermic) techniques to maintain liver health before surgery. Known as Sequential Hypo- and Normo-thermic Perfusion, this approach aims to improve the quality of livers from donors with extended criteria, which may not be perfect but remain usable. Individuals scheduled for a full liver transplant might be suitable candidates for this study. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance liver transplant outcomes.
Do I have to stop taking my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this perfusion device is safe for liver transplantation?
Research has shown that using different temperature techniques to prepare livers for transplants is promising. In one study, 94% of the transplanted livers functioned well after a year, and all patients survived. Only 3% of patients experienced bile duct issues, the main problem observed. Overall, this method was well-tolerated, with no major safety concerns reported. These findings suggest that this approach is safe for preserving donor livers before transplantation.12345
Why are researchers excited about this trial?
Most liver transplant preservation methods rely on cold storage, which can limit the organ's viability and function. The treatment being explored, Sequential Hypo- and Normo-thermic Perfusion, is unique because it preserves liver grafts at both cold (hypothermic) and body-like (normothermic) temperatures using a specialized machine. This process maintains continuous oxygen delivery to the organ, potentially improving the liver's condition before transplantation. Researchers are excited because this method could enhance organ preservation, reduce damage, and increase the success rate of transplants compared to traditional cold storage techniques.
What evidence suggests that this perfusion device is effective for liver transplantation?
Research has shown that cold machine perfusion (HMP) helps preserve livers from donors who don't meet all the usual criteria. Warm machine perfusion (NMP) offers similar benefits and also allows doctors to assess the liver's condition. Studies have found that this method can increase the number of livers available for transplant. Specifically, one study found that using NMP improved the long-term survival of transplanted livers. This trial will evaluate the effectiveness of using both cold and warm perfusion in sequence, known as Sequential Hypo- and Normo-thermic Perfusion, as a method to prepare livers for transplant.13467
Who Is on the Research Team?
Koji Hashimoto, MD, PhD
Principal Investigator
The Cleveland Clinic
Are You a Good Fit for This Trial?
This trial is for adults aged 18 or older who are undergoing liver transplantation and can follow the study's procedures. They must understand and sign a consent form. It's not open to those who don't speak the language well, have mental incapacities, need multiple organ transplants, or are receiving partial grafts.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Ex Vivo Organ Preservation
Liver grafts are preserved using hypothermic and normothermic machine perfusion with continuous oxygen supply
Transplantation and Immediate Post-Transplant Care
Liver transplantation procedure followed by immediate post-transplant care according to clinical standards
Follow-up
Participants are monitored for safety and effectiveness after transplantation
What Are the Treatments Tested in This Trial?
Interventions
- Sequential Hypo- and Normo-thermic Perfusion
Trial Overview
The trial tests a new method of preserving donor livers using a special machine that cools them down (HMP) for 1-4 hours then warms them (NMP) for 1-14 hours before transplant. This technique aims to improve the condition of livers from donors that don't meet standard criteria.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Device: Liver Machine Perfusion (MP) Device The liver grafts will be preserved at hypothermic and normothermic temperature on the institutional-developed Liver MP Device, and have continuous perfusion with oxygen supply in the ex vivo organ preservation phase.
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Cleveland Clinic
Lead Sponsor
Koji Hashimoto
Lead Sponsor
Citations
Sequential hypothermic and normothermic perfusion ...
The purpose of this study was to assess the safety and feasibility of sequential hypothermic oxygenated perfusion and normothermic machine perfusion.
Sequential hypothermic and normothermic machine ...
We present the outcomes of sequential ex situ end‐ischemic DHOPE and NMP for high‐risk donor livers, comparing two protocols with two different oxygen carriers ...
Study Details | NCT04023773 | Sequential Hypo- and ...
Hypothermic machine perfusion (HMP) has been shown to be beneficial to preserve extended criteria donor (ECD) livers for transplantation. Normothermic machine ...
Long-term outcomes after hypothermic oxygenated ...
Our aim was to assess 5-year survival rates after transplantation of donor livers preserved by HOPE based on real-world data, in various patient.
Role of normothermic machine perfusion in liver ...
Studies showed that using normothermic machine perfusion can increase the pool of transplantable discarded livers and is a promising strategy to improve graft ...
Sequential hypothermic and normothermic perfusion ...
The purpose of this study was to assess the safety and feasibility of sequential hypothermic oxygenated perfusion and normothermic machine perfusion.
Excellent long-term outcomes after sequential hypothermic ...
Excellent long-term outcomes after sequential hypothermic and normothermic machine perfusion challenges the importance of functional donor warm ischemia time ...
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