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

14. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

40

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Wellington Andraus, MD, PhD
  • Telefonnummer: +5511982118909
  • E-Mail: wellington@usp.br

Studieren Sie die Kontaktsicherung

  • Name: Alexandre Santana, PhD
  • Telefonnummer: +5511931002779
  • E-Mail: alesantana@usp.br

Studienorte

  • Brasilien
    • São Paulo
      • São Paulo, São Paulo, Brasilien, 05403-000
        • Hospital Das Clinicas Da Faculdade De Medicina Da Universidade De Sao Paulo (Hc-Fmusp)
        • Kontakt:
          • Wellington Andraus, MD, PhD
          • Telefonnummer: +5511982118909
          • E-Mail: wellington@usp.br
        • Kontakt:
        • Hauptermittler:
          • Wellington Andraus, MD, PhD
        • Unterermittler:
          • Rubens Junior, MD, PhD
        • Unterermittler:
          • Alexandre Santana, PhD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Gerät: 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.
Aktiver Komparator: 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.
Verfahren: Static Cold Storage
Liver graft preservation using conventional static cold storage under hypothermic conditions until transplantation.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Incidence of Early Allograft Dysfunction (EAD)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Liver Function Tests (AST, ALT, Total Bilirubin)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Analysis of Perfusate Biomarkers
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Sao Paulo General Hospital

Mitarbeiter

XVIVO Perfusion

Ermittler

  • Hauptermittler: Wellington Andraus, MD, PhD, Hospital Das Clinicas Da Faculdade De Medicina Da Universidade De Sao Paulo (Hc-Fmusp)
  • Studienstuhl: Rubens Macedo Junior, MD, PhD, Hospital Das Clinicas Da Faculdade De Medicina Da Universidade De Sao Paulo (Hc-Fmusp)
  • Studienleiter: Alexandre Santana, PhD, Hospital Das Clinicas Da Faculdade De Medicina Da Universidade De Sao Paulo (Hc-Fmusp)

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

7. Mai 2026

Primärer Abschluss (Geschätzt)

7. Mai 2027

Studienabschluss (Geschätzt)

7. Mai 2028

Studienanmeldedaten

Zuerst eingereicht

6. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

14. Mai 2026

Zuerst gepostet (Tatsächlich)

19. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

19. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

14. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 7.497.991
  • 2025/08106-0 (Andere Zuschuss-/Finanzierungsnummer: São Paulo Research Foundation (FAPESP))

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

UNENTSCHIEDEN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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