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NCT Number: NCT05680246

Long-term Outcomes After Prolonged Dual Hypothermic Oxygenated Machine Perfusion of Donor Livers (DHOPEPROLONG)

End-ischemic dual hypothermic oxygenated machine perfusion (DHOPE) of human donor livers mitigates ischemia-reperfusion injury, resulting in a reduction of post-reperfusion syndrome, early allograft dysfunction and biliary complications, when compared with static cold storage. End-ischemic DHOPE can be used to prolong donor liver preservation time for up to 24 hours. According to IDEAL-D (Idea, Development, Exploration, Assessment, Long term study-Framework for Devices), scientific evidence for prolonged DHOPE has currently reached stage 3. Assessment of long-term outcomes after prolonged DHOPE preservation based on real-world data (i.e., IDEAL-D stage 4) is currently still lacking.

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Key information

Conditions

Liver Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Groningen

Groningen, 9713GZ, Netherlands

Location status: Recruiting

Location contact

Vincent E de Meijer, MD, PhD

CONTACT

[email protected]

+31503616161

Vincent E de Meijer, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

The aim of this study is to assess long-term outcomes after transplantation of donor livers preserved by prolonged hypothermic oxygenated machine perfusion (DHOPE-PRO).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (>18 years) who underwent liver transplantation of donor livers preserved with end-ischemic DHOPE for >4 hours

Exclusion criteria

  • None

Treatment and study plan

DHOPE-PRO

Device

Prolonged DHOPE preservation >4 hours

Primary outcomes

  1. Death-censored graft survival

    Time frame: Up to 5-years

    Death-censored graft survival, assessed by survival analysis methods.

Secondary outcomes

  1. Overall graft survival

    Time frame: Up to 5-years

    Overall graft survival, assessed by survival analysis methods.

  2. overall patient survival

    Time frame: Up to 5-years

    overall patient survival, assessed by survival analysis methods.

  3. arterial and biliary complication-free survival (ABCFS)

    Time frame: Up to 5-years

    arterial and biliary complication-free survival (ABCFS), assessed by survival analysis methods.

  4. incidence of biliary complications

    Time frame: Up to 5-years

    incidence of biliary complications

  5. incidence of vascular complications

    Time frame: Up to 5-years

    incidence of vascular complications

  6. incidence of acute cellular rejection

    Time frame: Up to 5-years

    incidence of acute cellular rejection

  7. incidence of chronic rejection

    Time frame: Up to 5-years

    incidence of chronic rejection

  8. incidence of re-transplantation

    Time frame: Up to 5-years

    incidence of re-transplantation

  9. incidence of recurrence of primary disease

    Time frame: Up to 5-years

    incidence of recurrence of primary disease (including recurrence of malignancies)

  10. incidence of new-onset chronic kidney disease

    Time frame: Up to 5-years

    incidence of new-onset chronic kidney disease

  11. incidence of new-onset diabetes after transplantation

    Time frame: Up to 5-years

    incidence of new-onset diabetes after transplantation

Study contacts

Contact information is provided by the study sponsor or research team.

Vincent E de Meijer, MD, PhD

CONTACT

[email protected]

+31503616161

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

Prospective Observational Study to Investigate Long-term Outcomes After Prolonged Dual Hypothermic Oxygenated Machine Perfusion of Human Donor Livers (DHOPEPROLONG)

Acronym: DHOPEPROLONG

Important dates

Study start
2023
Primary completion
2028
Study completion
2033
First posted
Jan 11, 2023
Registry last updated
May 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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