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Hypothermic Machine Perfusion for Liver Graft Preservation (HOPE-Liver)

14 maggio 2026 aggiornato da: University of Sao Paulo General Hospital

Prospective and Randomized Clinical Study of the Effect of Hypothermic Machine Perfusion on Liver Graft Preservation

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This is a prospective, single-center, randomized controlled clinical trial designed to evaluate the impact of hypothermic machine perfusion on liver graft preservation and post-transplant outcomes in adult liver transplantation.

Liver transplantation is the standard treatment for end-stage liver disease; however, outcomes are strongly influenced by graft quality. The increasing use of extended criteria donors has introduced additional challenges, as these grafts are more susceptible to ischemia-reperfusion injury, a key determinant of early graft dysfunction and post-transplant complications. Conventional static cold storage, although widely used, does not prevent ongoing anaerobic metabolism and progressive depletion of cellular energy stores, contributing to mitochondrial dysfunction, oxidative stress, and inflammatory activation upon reperfusion.

Hypothermic machine perfusion has emerged as an alternative preservation strategy by providing continuous oxygenated perfusion under controlled hypothermic conditions. This approach aims to preserve mitochondrial integrity, reduce metabolic stress, and mitigate ischemia-reperfusion injury, thereby potentially improving graft viability and expanding the utilization of marginal organs.

In this study, liver grafts from deceased donors will be allocated to either hypothermic machine perfusion or conventional static cold storage. Following procurement, grafts assigned to the intervention group will undergo ex situ hypothermic perfusion using an oxygenated preservation solution under controlled conditions, while the control group will follow standard institutional preservation protocols.

All transplant procedures and perioperative management will be conducted according to institutional standards. Post-transplant follow-up will include clinical and laboratory monitoring to assess graft function and detect complications.

Tipo di studio

Interventistico

Iscrizione (Stimato)

40

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Wellington Andraus, MD, PhD
  • Numero di telefono: +5511982118909
  • Email: wellington@usp.br

Backup dei contatti dello studio

  • Nome: Alexandre Santana, PhD
  • Numero di telefono: +5511931002779
  • Email: alesantana@usp.br

Luoghi di studio

  • Brasile
    • São Paulo
      • São Paulo, São Paulo, Brasile, 05403-000
        • Hospital Das Clinicas Da Faculdade De Medicina Da Universidade De Sao Paulo (Hc-Fmusp)
        • Contatto:
          • Wellington Andraus, MD, PhD
          • Numero di telefono: +5511982118909
          • Email: wellington@usp.br
        • Contatto:
        • Investigatore principale:
          • Wellington Andraus, MD, PhD
        • Sub-investigatore:
          • Rubens Junior, MD, PhD
        • Sub-investigatore:
          • Alexandre Santana, PhD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Hypothermic Machine Perfusion
Liver grafts are preserved using hypothermic machine perfusion prior to transplantation. Following procurement and an initial period of static cold storage, grafts undergo ex situ hypothermic oxygenated perfusion under controlled conditions before implantation.
Dispositivo: Hypothermic Machine Perfusion
Hypothermic 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.
Comparatore attivo: Static Cold Storage
Liver grafts are preserved using conventional static cold storage according to standard institutional protocols. Following procurement, grafts are maintained under hypothermic conditions without active perfusion or oxygenation until implantation.
Procedura: Static Cold Storage
Liver graft preservation using conventional static cold storage under hypothermic conditions until transplantation.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of Early Allograft Dysfunction (EAD)
Lasso di tempo: Within 7 days after transplantation
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.
Within 7 days after transplantation

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Liver Function Tests (AST, ALT, Total Bilirubin)
Lasso di tempo: At 7 days, 30 days, 6 months, and 1 year after transplantation
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.
At 7 days, 30 days, 6 months, and 1 year after transplantation
Incidence of Acute Kidney Injury (AKI)
Lasso di tempo: Within 7 days and up to 30 days after transplantation
Occurrence of acute kidney injury following liver transplantation, defined based on changes in serum creatinine levels according to established clinical criteria.
Within 7 days and up to 30 days after transplantation
Incidence of Post-Reperfusion Syndrome (PRS)
Lasso di tempo: During transplantation procedure
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.
During transplantation procedure
Incidence of Post-Transplant Complications
Lasso di tempo: Up to 1 year after transplantation
Occurrence of post-transplant complications, including biliary complications, vascular complications, infections, and acute rejection, assessed according to standard clinical definitions and severity grading systems.
Up to 1 year after transplantation
Graft Survival
Lasso di tempo: Up to 1 year after transplantation
Survival of the transplanted liver graft without the need for retransplantation
Up to 1 year after transplantation
Patient Survival
Lasso di tempo: Up to 1 year after transplantation
Survival of the transplant recipient following liver transplantation.
Up to 1 year after transplantation
Length of Intensive Care Unit Stay
Lasso di tempo: From liver transplantation until intensive care unit discharge, up to 30 days
Duration of stay in the intensive care unit following liver transplantation.
From liver transplantation until intensive care unit discharge, up to 30 days
Length of Hospital Stay
Lasso di tempo: From liver transplantation until hospital discharge, up to 30 days
Duration of hospital stay following liver transplantation.
From liver transplantation until hospital discharge, up to 30 days

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Analysis of Perfusate Biomarkers
Lasso di tempo: During machine perfusion and immediately prior to transplantation
Assessment of biochemical and metabolic biomarkers in perfusate samples collected during hypothermic machine perfusion, aiming to evaluate graft viability and ischemia-reperfusion injury.
During machine perfusion and immediately prior to transplantation
Assessment of Mitochondrial Function Biomarkers (Flavin Mononucleotide, FMN)
Lasso di tempo: During machine perfusion period
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.
During machine perfusion period
Assessment of Inflammatory Biomarkers
Lasso di tempo: During machine perfusion and within the first 7 days after transplantation
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.
During machine perfusion and within the first 7 days after transplantation
Histological Assessment of Liver Graft Injury
Lasso di tempo: During the perioperative period, including before and after machine perfusion and prior to transplantation
Histological evaluation of liver tissue samples to assess ischemia-reperfusion injury, inflammation, and structural integrity of the graft.
During the perioperative period, including before and after machine perfusion and prior to transplantation

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Sao Paulo General Hospital

Collaboratori

XVIVO Perfusion

Investigatori

  • Investigatore principale: Wellington Andraus, MD, PhD, Hospital Das Clinicas Da Faculdade De Medicina Da Universidade De Sao Paulo (Hc-Fmusp)
  • Cattedra di studio: Rubens Macedo Junior, MD, PhD, Hospital Das Clinicas Da Faculdade De Medicina Da Universidade De Sao Paulo (Hc-Fmusp)
  • Direttore dello studio: Alexandre Santana, PhD, Hospital Das Clinicas Da Faculdade De Medicina Da Universidade De Sao Paulo (Hc-Fmusp)

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

7 maggio 2026

Completamento primario (Stimato)

7 maggio 2027

Completamento dello studio (Stimato)

7 maggio 2028

Date di iscrizione allo studio

Primo inviato

6 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

14 maggio 2026

Primo Inserito (Effettivo)

19 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

19 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 7.497.991
  • 2025/08106-0 (Altro numero di sovvenzione/finanziamento: São Paulo Research Foundation (FAPESP))

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

No final decision has been made regarding the sharing of individual participant data (IPD). The study involves clinical data and biological samples, including biomarker analyses, which require careful consideration regarding data anonymization, ethical approvals, and institutional policies. A data sharing plan may be developed in the future in accordance with applicable regulations and journal requirements.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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