End Stage Liver DiseaseVIHOMPSNCT06418165
Vienna Hypothermic Oxygenated Machine Perfusion Study
An observational study of End Stage Liver Disease and Hepatocellular Carcinoma, run by Medical University of Vienna at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Liver Disease, Hepatocellular Carcinoma
- How many people
- 500 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jan 2018to 31 Dec 2038
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients listed for and undergoing liver transplantation using a liver graft which was subjected to hypothermic oxygenated machine perfusion
Who may be able to join
- patients undergoing liver transplantation with the use of hypothermic oxygenated machine perfusion
- age ≥ 18 years
Who cannot join
- pregnancy
- partial grafts
- the anatomical integrity of the liver is not preserved in a way that makes the perfusion of the liver possible
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
David Pereyra, MD, PhD, +4314040056210, david.pereyra@muv.ac.at
Jule Dingfelder, MD, +4314040056210, jule.dingfelder@muv.ac.at
About this study
Official title: Vienna Hypothermic Oxygenated Machine Perfusion for Liver Transplantation Study
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
- Medical subject headings
- End Stage Liver Disease, Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ischemic-type biliary lesions
Non-anastomotic stenosis, post-transplant cholangiopathy
Measured: Within one year after liver transplantation
Secondary outcomes (3)
Rate of early allograft dysfunction
Deviation of bilirubin, transaminases or international normalised ratio
Measured: Evaluated within the first 7 postoperative days
Rate of primary non-function
Measured: Evaluated in the immediate postoperative period, specifically within the first postoperative week
Incidence of re-transplantation
Measured: Evaluated in the immediate postoperative period, specifically within the first postoperative week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start1 Jan 2018
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Pereyra, Medical University of Vienna
- Investigators
- Gabriela A Berlakovich, Prof, MD, Study chair, Medical University of Vienna, Division of TransplantationGeorg Györi, MD, Study director, Medical University of Vienna, Division of Transplantation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06418165
- Sponsor's protocol ID
- 1610/2023
- Acronym
- VIHOMPS
- Status last verified
- May 2024
- First submitted
- 10 May 2024
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: data available upon reasonable request and in accordance with appropriate data sharing agreements
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.
PubMed 39422535
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vienna Hypothermic Oxygenated Machine Perfusion for Liver Transplantation Study
- ClinicalTrials.gov ID
- NCT06418165
- Acronym / sponsor ID
- VIHOMPS / 1610/2023
- Conditions
- End Stage Liver Disease, Hepatocellular Carcinoma
- Keywords
- Liver Transplantation, Hypothermic Oxygenated Machine Perfusion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2038 (estimated)
- First posted
- 17 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients listed for and undergoing liver transplantation using a liver graft which was subjected to hypothermic oxygenated machine perfusion
Key inclusion criteria (2 listed)
- patients undergoing liver transplantation with the use of hypothermic oxygenated machine perfusion
- age ≥ 18 years
Key exclusion criteria (3 listed)
- pregnancy
- partial grafts
- the anatomical integrity of the liver is not preserved in a way that makes the perfusion of the liver possible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of ischemic-type biliary lesions
Time frame: Within one year after liver transplantation
Non-anastomotic stenosis, post-transplant cholangiopathy
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Derived from this study: PubMed 39422535Pereyra 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.
- Individual participant dataSharing planned: Undecided. data available upon reasonable request and in accordance with appropriate data sharing agreements
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Liver Disease and Hepatocellular Carcinoma, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Pereyra, MD, PhD (+4314040056210, david.pereyra@muv.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of ischemic-type biliary lesions (time frame: Within one year after liver transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06418165, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.