Assessing Declined Liver Grafts With Normothermic Machine Perfusion to Reduce Transplant Waiting Time
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCharite University, Berlin, Germany
About this trial
The goal of this study is to find out if quality assessment by normothermic machine perfusion can be used to safely increase the number of usable donor livers, helping more people get transplants faster and with better results. This process keeps a donated liver working outside the body before transplantation, allowing surgeons to assess whether livers previously considered unsuitable can still be used.
The main questions this study aims to answer are:
* Does this method help patients get a transplant sooner? * Can this method make more livers available for transplant? * Does it improve survival and health after transplant?
Participants in this study must be on the waiting list for a liver transplant with a ReMELD-Na-Score of 21 or less (equivalent to MELD ≤25) and must not qualify for certain special exceptions. Participants will be randomly placed into one of two groups:
* Experimental group: In addition to regular organ offers, these participants may receive a liver that was initially not considered for transplantation but meets quality standards after at least four hours of machine perfusion. * Control group: These participants will receive a liver through the usual transplant process.
The main measure of success is how quickly participants receive a transplant. Researchers will also look at other important factors, such as survival rates, quality of life, hospital stay, and complications after transplant.
This study may help improve liver transplantation by making better use of available donor livers, reducing waiting times, and improving patient outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Able to consent
≥ 18 years old
Listed in status "transplantable" by the transplant conference of the study centre for liver transplantation, according to the guidelines of the German Medical Association valid at the time of inclusion
ReMELD-Na-Score ≤ 21 (equivalent to MELD ≤25), not eligible for [non]standard exceptions
Disqualifiers
Listed for retransplantation
High-Urgency Listing
Listed for combined organ transplantation
Pregnancy
Trial design
Design model
Parallel
Treatments tested in this trial
Quality Assessment with Normothermic Machine Perfusion (NMP)
DeviceQuality assessment using NMP in the experimental arm is performed according to previously published viability criteria for initially declined liver grafts, which are mandatory for all participating study centers, with minor device-specific modifications. These criteria are based on the Birmingham criteria used in the VITTAL trial for viability assessment of DBD and DCD grafts with the OrganOx Metra device and are comparable to the Groningen criteria used with the LiverAssist and PerLife device, with the exception of biliary viability. These criteria are: Lactate clearance \< 2.5 mmol/L, And two or more of the following: Evidence of bile production, maintenance of a perfusate pH \>7.30 (without correction for at least one hour), glucose metabolism (falling perfusate glucose value with consistent downward trend), maintenance of stable arterial and portal venous flows (OrganOx Metra: 150 and 500 mL/min respectively), homogeneous perfusion with soft consistency of the parenchyma.
Treatment groups
186 Participants
are divided into 2 treatment groupsGroup A: Standard of careNo intervention 0 interventions
Group B: ExTra OptionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Time-to-Transplant
Time frame
From date of randomization to liver transplantation (up to 12 months after date of randomization)Secondary outcomes
1
Death
Patient death during the 12-month intervention period, regardless of liver transplantation or not.
Time frame
From date of randomization to death (up to 12 months after date of randomization)2
Disease Progression
Change of ReMELD-Na-Score above 21 while listed as "transplantable" on the waitlist. Occurence of new contraindication for liver transplantation
Time frame
From date of randomization to event (up to 12 months after date of randomization)3
Proportion of Patients Recovered on the Waitlist
Proportion of patients with change in overall health that no liver transplantation is further required in relation to all patients on the waitlist in the trial.
Time frame
From date of randomization to event (up to 12 months after date of randomization)4
Number of patients listed for transplantation after 12 months
Number of patients listed for transplantation after 12 months.
Time frame
12 months after randomizationOther outcomes
1
3-month Graft Survival
Graft survival is defined as the need for retransplantation within the first 3 months after liver transplantation. This is one of the "Safety" endpoints and will be evaluated by the Data Safety Monitoring Board.
Time frame
Within 3 months after date of liver transplantation2
3-month Patient Survival
Patient survival is defined as death within the first 3 months after liver transplantation. This is one of the "Safety" endpoints and will be evaluated by the Data Safety Monitoring Board.
Time frame
Within 3 months after date of liver transplantation3
Patient Survival
Patient Survival after liver transplantation
Time frame
12 months after liver transplantation4
Early graft function
Early graft function measured by the Early Allograft Failure Simplified Estimation (EASE) Score on a scale from -6 (extremely low risk) to +6 (unsustainable risk).
Time frame
Until 10 days after liver transplantationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Charite University, Berlin, Germany
Lead sponsor
German Research Foundation
Collaborator
Source ClinicalTrials.gov