Usefulness of Alpha-GST in Liver Transplantation

Evidence of Liver Transplantation Clinical Trial

— GST-LT  

Official title:

Predictive Ability of Alpha-GST to Detect Graft Primary Dysfunction After Liver Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02451046
• Other study ID #: 2015-A00839-40
• Status: Recruiting
• Phase: N/A
• First received: May 19, 2015
• Last updated: May 20, 2015
• Start date: March 2014
• Est. completion date: October 2015

Study information

• Verified date: May 2015
• Source: Beaujon Hospital
• Contact: Catherine Paugam-Burtz, MD-PhD
• Phone: 140875610
• Email: catherine.paugam[@]bjn.aphp.fr
• Is FDA regulated: No
• Health authority: France: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• age > 18 years

• undergoing liver transplantation at Beaujon hospital (APHP, Clichy, France )

Exclusion Criteria:

• age >70 years and <18 years

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Evidence of Liver Transplantation

Locations

Country	Name	City	State
France	Réanimation hépato-digestive	Clichy

Sponsors (1)

Lead Sponsor	Collaborator
Beaujon Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary dysfunction (PDF) of liver graft	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	No
Secondary	Early graft function recovery.	To study the relationship between alpha-GST levels in the plasma of the liver transplant recipient and early graft function recovery.	First week	No