- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02451046
Usefulness of Alpha-GST in Liver Transplantation (GST-LT)
May 20, 2015 updated by: Paugam-Burtz, Beaujon Hospital
Predictive Ability of Alpha-GST to Detect Graft Primary Dysfunction After Liver Transplantation
The primary objective of this study was to evaluate the ability of plasma alpha-GST measurements in liver donor (at the time of organ removal) to predict primary dysfunction in liver recipient.
The secondary objective was to study the relationship between alpha-GST levels in the plasma of the liver transplant recipient and early graft function recovery.
Study Overview
Status
Unknown
Conditions
Detailed Description
Graft primary dysfunction (PDF) after liver transplantation is enhanced by the increasing use of extended-criteria allografts.
This complication is burdened with high mortality and morbidity rates among liver transplant recipients.
Alpha-GST is a short-life hepatocyte enzyme that may be an interesting biomarker for liver injury.
A recently developped ELISA technique may allow fast and easy measurement of alpha-GST plasma concentration (Fastpack IP α-GST Immunoassay, Qualigen Inc., Carlsbad, CA).
This study aims to evaluate the ability of plasma alpha-GST measurements in liver donor to predict PDF in liver recipient.
Methods: Observational study conducted in one center (Beaujon hospital, APHP, Clichy, France).
Measurements of plasma levels of alpha-GST using Fastpack IP α-GST Immunoassay (Qualigen Inc., Carlsbad, CA) at the time of organ removal in liver donor and daily from day 0 to day 7 after liver transplantation in recipients.
Study Type
Observational
Enrollment (Anticipated)
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 Contact
- Name: Catherine Paugam-Burtz, MD-PhD
- Phone Number: +33 140875610
- Email: catherine.paugam@bjn.aphp.fr
Study Contact Backup
- Name: Emmanuel Weiss, MD
- Phone Number: +33 603004193
- Email: manuweiss@yahoo.fr
Study Locations
-
-
-
Clichy, France, F-92210
- Recruiting
- Réanimation hépato-digestive
-
Contact:
- Catherine Paugam-Burtz, MD-PhD
- Phone Number: +33 140875610
- Email: catherine.paugam@bjn.aphp.fr
-
Contact:
- Emmanuel Weiss, MD
- Phone Number: +33 603004193
- Email: manuweiss@yahoo.fr
-
-
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
Non-Probability Sample
Study Population
Patients undergoing liver transplantation at Beaujon hospital (APHP, Clichy, France)
Description
Inclusion Criteria:
- age > 18 years
- undergoing liver transplantation at Beaujon hospital (APHP, Clichy, France )
Exclusion Criteria:
- age >70 years and <18 years
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary dysfunction (PDF) of liver graft
Time Frame: First week
|
To evaluate the ability of plasma alpha-GST measurements in liver donor (at the time of organ removal) to PDF in liver recipient.
|
First week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Early graft function recovery.
Time Frame: First week
|
To study the relationship between alpha-GST levels in the plasma of the liver transplant recipient and early graft function recovery.
|
First week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Catherine Paugam-Burtz, MD-PhD, Assistance Publique - Hôpitaux de Paris
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
March 1, 2014
Primary Completion (Anticipated)
October 1, 2015
Study Completion (Anticipated)
October 1, 2015
Study Registration Dates
First Submitted
May 19, 2015
First Submitted That Met QC Criteria
May 20, 2015
First Posted (Estimate)
May 21, 2015
Study Record Updates
Last Update Posted (Estimate)
May 21, 2015
Last Update Submitted That Met QC Criteria
May 20, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2015-A00839-40
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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