- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02695979
Changes of Macrophage Migration Inhibitory Factor During Orthotopic Liver Transplantation
February 28, 2018 updated by: Dr. Joanna Stefaniak, Medical University of Vienna
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.
Study Overview
Status
Unknown
Conditions
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 Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Vienna, Austria, 1090
- Medical University Vienna
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients undergoing orthotopic liver transplantation
Description
Inclusion Criteria:
- End stage liver disease, chronic liver failure, orthotopic liver transplantation
Exclusion Criteria:
- Combined transplantations (liver plus kidney or lung), age under 18 y, acute liver failure
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Patients undergoing OLT
Patients aged 18-70 with end-stage liver disease undergoing orthotopic liver transplantation (OLT).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Macrophage Migration Inhibitory Factor in human serum, liver graft effluent and urine
Time Frame: 24 months
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24 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Acute kidney injury, outcome
Time Frame: 48 months
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Acute kidney injury, outcome
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48 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Peter Faybik, Prof, Medical University Vienna, Department of Anesthesia, General Intensive Care and Pain Management
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Anticipated)
September 1, 2018
Study Completion (Anticipated)
August 1, 2019
Study Registration Dates
First Submitted
January 12, 2016
First Submitted That Met QC Criteria
February 24, 2016
First Posted (Estimate)
March 2, 2016
Study Record Updates
Last Update Posted (Actual)
March 1, 2018
Last Update Submitted That Met QC Criteria
February 28, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 1458/2014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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