Hypothermic Machine Perfusion for Liver Graft Preservation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Sao Paulo General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Liver donors with confirmed diagnosis of brain death.
Extended criteria donors (ECD).
Age ≥18 years.
Family consent for organ donation obtained.
Disqualifiers
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
Complex portal vein thrombosis (grade III or IV).
Trial design
Design model
Parallel
Treatments tested in this trial
Hypothermic Machine Perfusion
DeviceHypothermic machine perfusion of the liver graft is performed prior to transplantation using an ex situ perfusion system under controlled conditions, in which an oxygenated perfusate is circulated through the liver graft vasculature.
Static Cold Storage
Procedure/SurgeryLiver graft preservation using conventional static cold storage under hypothermic conditions until transplantation.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Hypothermic Machine PerfusionExperimental treatment 1 intervention
Group B: Static Cold StorageActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Early Allograft Dysfunction (EAD)
Early allograft dysfunction is defined according to established clinical criteria, including at least one of the following within the first 7 days after transplantation: total bilirubin ≥10 mg/dL on day 7, international normalized ratio (INR) ≥1.6 on day 7, or alanine or aspartate aminotransferase (ALT or AST) levels \>2000 IU/L within the first 7 days.
Time frame
Within 7 days after transplantationSecondary outcomes
1
Change in Liver Function Tests (AST, ALT, Total Bilirubin)
Serial measurements of liver function parameters, including aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin, obtained through routine laboratory testing following liver transplantation. Values will be analyzed over time to assess graft function and recovery.
Time frame
At 7 days, 30 days, 6 months, and 1 year after transplantation2
Incidence of Acute Kidney Injury (AKI)
Occurrence of acute kidney injury following liver transplantation, defined based on changes in serum creatinine levels according to established clinical criteria.
Time frame
Within 7 days and up to 30 days after transplantation3
Incidence of Post-Reperfusion Syndrome (PRS)
Occurrence of post-reperfusion syndrome during liver transplantation, defined as a decrease in mean arterial pressure greater than 30% from baseline within the first minutes after graft reperfusion, with or without the need for increased vasopressor support.
Time frame
During transplantation procedure4
Incidence of Post-Transplant Complications
Occurrence of post-transplant complications, including biliary complications, vascular complications, infections, and acute rejection, assessed according to standard clinical definitions and severity grading systems.
Time frame
Up to 1 year after transplantationOther outcomes
1
Analysis of Perfusate Biomarkers
Assessment of biochemical and metabolic biomarkers in perfusate samples collected during hypothermic machine perfusion, aiming to evaluate graft viability and ischemia-reperfusion injury.
Time frame
During machine perfusion and immediately prior to transplantation2
Assessment of Mitochondrial Function Biomarkers (Flavin Mononucleotide, FMN)
Measurement of mitochondrial injury and function through biomarkers such as flavin mononucleotide (FMN) in perfusate and/or biological samples, as an indicator of ischemia-reperfusion injury and graft viability.
Time frame
During machine perfusion period3
Assessment of Inflammatory Biomarkers
Evaluation of inflammatory mediators, including cytokines such as interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-α), in biological samples to characterize the inflammatory response associated with transplantation and preservation strategies.
Time frame
During machine perfusion and within the first 7 days after transplantation4
Histological Assessment of Liver Graft Injury
Histological evaluation of liver tissue samples to assess ischemia-reperfusion injury, inflammation, and structural integrity of the graft.
Time frame
During the perioperative period, including before and after machine perfusion and prior to transplantationSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Sao Paulo General Hospital
Lead sponsor
XVIVO Perfusion
Collaborator
Source ClinicalTrials.gov
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