Vienna Hypothermic Oxygenated Machine Perfusion Study

Recruiting

• Conditions: End Stage Liver Disease; Hepatocellular Carcinoma

• Registration Number: NCT06418165
• Lead Sponsor: Medical University of Vienna

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Status Verified: 2024-05
• Study First Submitted: 2024-05-10
• Study First Submitted QC: 2024-05-15
• Last Update Submitted: 2024-05-15
• Study First Posted: 2024-05-17
• Last Update Posted: 2024-05-17
• Primary Completion: 2028-12-31
• Study Completion: 2038-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of ischemic-type biliary lesions	Within one year after liver transplantation	Non-anastomotic stenosis, post-transplant cholangiopathy

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria