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NCT Number: NCT06418165

Vienna Hypothermic Oxygenated Machine Perfusion Study

In this observational cohort study data on all patients undergoing liver transplantation after hypothermic oxygenated machine perfusion at Medical University of Vienna will be prospectively recorded. Investigation of short- and long-term outcome in this cohort will be conducted.

Recruiting

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Key information

Conditions

End Stage Liver Disease Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Hepatic Insufficiency Hepatocellular Carcinoma Liver Diseases Liver Failure Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Vienna

Vienna, 1090, Austria

Location status: Recruiting

Location contact

Andreas Salat, Prof, MD

SUB_INVESTIGATOR

David Pereyra, MD, PhD

CONTACT

[email protected]

+4314040056210

Gabriela A Berlakovich, Prof, MD

SUB_INVESTIGATOR

Georg Györi, MD

SUB_INVESTIGATOR

Gerd Silberhumer, Prof, MD

SUB_INVESTIGATOR

Jule Dingfelder, MD

CONTACT

[email protected]

+4314040056210

Julia Jedamzik, MD

SUB_INVESTIGATOR

Thomas Soliman, Prof, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients undergoing liver transplantation with the use of hypothermic oxygenated machine perfusion
  • age ≥ 18 years

Exclusion criteria

  • pregnancy
  • partial grafts
  • the anatomical integrity of the liver is not preserved in a way that makes the perfusion of the liver possible

Treatment and study plan

Primary outcomes

  1. Incidence of ischemic-type biliary lesions

    Time frame: Within one year after liver transplantation

    Non-anastomotic stenosis, post-transplant cholangiopathy

Secondary outcomes

  1. Rate of early allograft dysfunction

    Time frame: Evaluated within the first 7 postoperative days

    Deviation of bilirubin, transaminases or international normalised ratio

  2. Rate of primary non-function

    Time frame: Evaluated in the immediate postoperative period, specifically within the first postoperative week

  3. Incidence of re-transplantation

    Time frame: Evaluated in the immediate postoperative period, specifically within the first postoperative week

Study contacts

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

David Pereyra, MD, PhD

CONTACT

[email protected]

+4314040056210

Jule Dingfelder, MD

CONTACT

[email protected]

+4314040056210

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Vienna Hypothermic Oxygenated Machine Perfusion for Liver Transplantation Study

Acronym: VIHOMPS

Important dates

Study start
2018
Primary completion
2028
Study completion
2038
First posted
May 17, 2024
Registry last updated
May 17, 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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