Vienna Hypothermic Oxygenated Machine Perfusion Study

NCT06418165 | Recruiting

• 1 other identifier: 1610/2023
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Liver Disease; Hepatocellular Carcinoma

Keywords

Liver Transplantation; Hypothermic Oxygenated Machine Perfusion

Outcome Measures

Primary Outcomes (1)

• Incidence of ischemic-type biliary lesions

  Non-anastomotic stenosis, post-transplant cholangiopathy

  Within one year after liver transplantation

Secondary Outcomes (3)

• Rate of early allograft dysfunction

  Evaluated within the first 7 postoperative days

• Rate of primary non-function

  Evaluated in the immediate postoperative period, specifically within the first postoperative week

• Incidence of re-transplantation

  Evaluated in the immediate postoperative period, specifically within the first postoperative week

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

End Stage Liver Disease; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site

Study Officials

• Gabriela A Berlakovich, Prof, MD

  Medical University of Vienna, Division of Transplantation

  STUDY CHAIR

• Georg Györi, MD

  Medical University of Vienna, Division of Transplantation

  STUDY DIRECTOR

Central Study Contacts

David Pereyra, MD, PhD

CONTACT

+4314040056210; david.pereyra@muv.ac.at

Jule Dingfelder, MD

CONTACT

+4314040056210; jule.dingfelder@muv.ac.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 17, 2024
• Study Start: January 1, 2018
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2038
• Last Updated: May 17, 2024

Record last verified: 2024-05

Locations

AU (1)