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Recruiting NCT06418165

Vienna Hypothermic Oxygenated Machine Perfusion Study

Observational End Stage Liver Disease Hepatocellular Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: End Stage Liver Disease, Hepatocellular Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Vienna Hypothermic Oxygenated Machine Perfusion for Liver Transplantation Study

Overview

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.

Primary outcome measures

  • Incidence of ischemic-type biliary lesions [Time frame: Within one year after liver transplantation]
Secondary outcome measures (3)
  • Rate of early allograft dysfunction [Time frame: 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]
  • Incidence of re-transplantation [Time frame: Evaluated in the immediate postoperative period, specifically within the first postoperative week]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Austria · 1 center
  • Medical University of Vienna — Vienna

Publications

  • Pereyra D, Dingfelder J, Riha M, Kacar S, Rauter L, Becker N, Saffarian Zadeh T, Tortopis C, Starlinger P, Ristl R, Silberhumer G, Salat A, Soliman T, Berlakovich G, Gyoeri G. Dual hypothermic oxygenated machine perfusion of the liver reduces post-transplant biliary complications: a retrospective cohort study. Int J Surg. 2024 Dec 1;110(12):7909-7918. doi: 10.1097/JS9.0000000000002115. PMID 39422535

Identifiers

NCT: NCT06418165 · 1610/2023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗