Evidence of Liver TransplantationNCT02695979
Changes of Macrophage Migration Inhibitory Factor During Orthotopic Liver Transplantation
An observational study of Evidence of Liver Transplantation, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Collecting blood, graft liver effluent and urine samples from patients undergoing orthotopic liver transplantation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Evidence of Liver Transplantation
- How many people
- 100 participants
- Where
- 1 siteAustria
- Study dates
- Aug 2014to Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing orthotopic liver transplantation
Who may be able to join
- End stage liver disease, chronic liver failure, orthotopic liver transplantation
Who cannot join
- Combined transplantations (liver plus kidney or lung), age under 18 y, acute liver failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes of Macrophage Migration Inhibitory Factor and Thyroid Hormones During Liver Transplantation. Association With Graft Dysfunction
Collecting blood, graft liver effluent and urine samples from patients undergoing orthotopic liver transplantation.
Read the detailed description
Aims are to measure Macrophage Migration Inhibitory Factor, Macrophage Migration Inhibitory Factor II and its' soluble receptor CD74 in serum, liver graft effluent and urine in and evaluate MIF's role in hepatic ischemia/reperfusion injury, postoperative graft function and kidney function.
- Conditions
- Evidence of Liver Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing OLT | Patients aged 18-70 with end-stage liver disease undergoing orthotopic liver transplantation (OLT). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macrophage Migration Inhibitory Factor in human serum, liver graft effluent and urine
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2016 (estimated)
- Study startAug 2014
- Primary completionSep 2018 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evidence of Liver TransplantationStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Joanna Stefaniak, Medical University of Vienna
- Investigators
- Peter Faybik, Prof, Study chair, Medical University Vienna, Department of Anesthesia, General Intensive Care and Pain Management
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02695979
- Sponsor's protocol ID
- 1458/2014
- Status last verified
- Feb 2018
- First submitted
- 12 Jan 2016
- Last updated
- 1 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of Macrophage Migration Inhibitory Factor and Thyroid Hormones During Liver Transplantation. Association With Graft Dysfunction
- ClinicalTrials.gov ID
- NCT02695979
- Acronym / sponsor ID
- 1458/2014
- Conditions
- Evidence of Liver Transplantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 2 Mar 2016 (estimated)
- 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.
Collecting blood, graft liver effluent and urine samples from patients undergoing orthotopic liver transplantation.
Detailed description
Aims are to measure Macrophage Migration Inhibitory Factor, Macrophage Migration Inhibitory Factor II and its' soluble receptor CD74 in serum, liver graft effluent and urine in and evaluate MIF's role in hepatic ischemia/reperfusion injury, postoperative graft function and kidney function.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing OLT | – | –Patients aged 18-70 with end-stage liver disease undergoing orthotopic liver transplantation (OLT). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing orthotopic liver transplantation
Key inclusion criteria (1 listed)
- End stage liver disease, chronic liver failure, orthotopic liver transplantation
Key exclusion criteria (1 listed)
- Combined transplantations (liver plus kidney or lung), age under 18 y, acute liver failure
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
Macrophage Migration Inhibitory Factor in human serum, liver graft effluent and urine
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Peter Faybik, Prof study chair
Medical University Vienna, Department of Anesthesia, General Intensive Care and Pain Management
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 Evidence of Liver Transplantation, 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 Mar 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Macrophage Migration Inhibitory Factor in human serum, liver graft effluent and urine (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Mar 2018.