Vienna Hypothermic Oxygenated Machine Perfusion Study

Hepatocellular Carcinoma Clinical Trial

— VIHOMPS  

Official title:

Vienna Hypothermic Oxygenated Machine Perfusion for Liver Transplantation Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06418165
• Other study ID #: 1610/2023
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: December 31, 2038

Study information

• Verified date: May 2024
• Source: Medical University of Vienna
• Contact: David Pereyra, MD, PhD
• Phone: +4314040056210
• Email: david.pereyra[@]muv.ac.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2038
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Liver Disease
• Hepatocellular Carcinoma
• Hypothermia
• Liver Diseases

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of ischemic-type biliary lesions	Non-anastomotic stenosis, post-transplant cholangiopathy	Within one year after liver transplantation
Secondary	Rate of early allograft dysfunction	Deviation of bilirubin, transaminases or international normalised ratio	Evaluated within the first 7 postoperative days
Secondary	Rate of primary non-function		Evaluated in the immediate postoperative period, specifically within the first postoperative week
Secondary	Incidence of re-transplantation		Evaluated in the immediate postoperative period, specifically within the first postoperative week