Vienna Hypothermic Oxygenated Machine Perfusion Study (VIHOMPS)

May 15, 2024 updated by: David Pereyra, Medical University of Vienna

Vienna Hypothermic Oxygenated Machine Perfusion for Liver Transplantation 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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Recruiting
        • Medical University of Vienna
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Gabriela A Berlakovich, Prof, MD
        • Sub-Investigator:
          • Georg Györi, MD
        • Sub-Investigator:
          • Thomas Soliman, Prof, MD
        • Sub-Investigator:
          • Andreas Salat, Prof, MD
        • Sub-Investigator:
          • Gerd Silberhumer, Prof, MD
        • Sub-Investigator:
          • Julia Jedamzik, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients listed for and undergoing liver transplantation using a liver graft which was subjected to hypothermic oxygenated machine perfusion

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of ischemic-type biliary lesions
Time Frame: Within one year after liver transplantation
Non-anastomotic stenosis, post-transplant cholangiopathy
Within one year after liver transplantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of early allograft dysfunction
Time Frame: Evaluated within the first 7 postoperative days
Deviation of bilirubin, transaminases or international normalised ratio
Evaluated within the first 7 postoperative days
Rate of primary non-function
Time Frame: Evaluated in the immediate postoperative period, specifically within the first postoperative week
Evaluated in the immediate postoperative period, specifically within the first postoperative week
Incidence of re-transplantation
Time Frame: Evaluated in the immediate postoperative period, specifically within the first postoperative week
Evaluated in the immediate postoperative period, specifically within the first postoperative week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Study Chair: Gabriela A Berlakovich, Prof, MD, Medical University of Vienna, Division of Transplantation
  • Study Director: Georg Györi, MD, Medical University of Vienna, Division of Transplantation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2038

Study Registration Dates

First Submitted

May 10, 2024

First Submitted That Met QC Criteria

May 15, 2024

First Posted (Actual)

May 17, 2024

Study Record Updates

Last Update Posted (Actual)

May 17, 2024

Last Update Submitted That Met QC Criteria

May 15, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1610/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

data available upon reasonable request and in accordance with appropriate data sharing agreements

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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