ClinicalTrials.gg
Sign In
RecruitingNCT06418165VIHOMPSUpdated May 17, 2024

Vienna Hypothermic Oxygenated Machine Perfusion Study

An observational study in End Stage Liver Disease and Hepatocellular Carcinoma, sponsored by Medical University of Vienna. Recruiting at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-17.

Sponsored by Medical University of Vienna · Observational

From the registry’s dates

  • Started Jan 2018; still recruiting 8 years 10 months later.

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • End Stage Liver Disease
  • Hepatocellular Carcinoma

Keywords

  • Liver Transplantation
  • Hypothermic Oxygenated Machine Perfusion
03

In context

End Stage Liver Disease

155 studies on the registry are indexed under End Stage Liver Disease; 31 are open to participants now.

This study's planned enrollment of 500 is above the median of 200 across 55 observational studies indexed under End Stage Liver Disease.

Browse End Stage Liver Disease studies →

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,109 studies on the registry; 184 are open to participants now.

Browse Medical University of Vienna studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Incidence of ischemic-type biliary lesions

    Non-anastomotic stenosis, post-transplant cholangiopathy

    Time frame: Within one year after liver transplantation

Secondary outcomes

  1. Rate of early allograft dysfunction

    Deviation of bilirubin, transaminases or international normalised ratio

    Time frame: Evaluated within the first 7 postoperative days

  2. Rate of primary non-function

    Time frame: Evaluated in the immediate postoperative period, specifically within the first postoperative week

  3. Incidence of re-transplantation

    Time frame: Evaluated in the immediate postoperative period, specifically within the first postoperative week

07

Study locations

1 of 1 sites recruiting
  • Medical University of Vienna
    Vienna, 1090, Austria
    Recruiting
    • David Pereyra, MD, PhD · Contactdavid.pereyra@muv.ac.at · +4314040056210
    • Jule Dingfelder, MD · Contactjule.dingfelder@muv.ac.at · +4314040056210
    • 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 · Sub investigator
08

References and documents

Individual participant data

Plan to share: Undecided — data available upon reasonable request and in accordance with appropriate data sharing agreements

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2018 (actual). Primary completion is estimated for Dec 2028, 131 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 10, 2024
First posted
May 17, 2024
StartActual
Jan 1, 2018
Primary completionEst.
Dec 31, 2028
CompletionEst.
Dec 31, 2038
Last update
May 17, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06418165
Lead sponsor
Medical University of Vienna
Responsible party
David Pereyra (Principal Investigator, Medical University of Vienna) — Principal investigator
First posted
May 17, 2024
Start date
Jan 1, 2018
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2038 (estimated)
Last update
May 17, 2024

Study contacts

David Pereyra, MD, PhD
Contact
david.pereyra@muv.ac.at
+4314040056210
Jule Dingfelder, MD
Contact
jule.dingfelder@muv.ac.at
+4314040056210
Gabriela A Berlakovich, Prof, MD
study chair · Medical University of Vienna, Division of Transplantation
Georg Györi, MD
study director · Medical University of Vienna, Division of Transplantation

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

End Stage Liver Disease →

Other studies from this sponsor

Medical University of Vienna →

Start the discussion