Usefulness of Alpha-GST in Liver Transplantation

• Conditions: Evidence of Liver Transplantation

• Registration Number: NCT02451046
• Lead Sponsor: Beaujon Hospital

Brief 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.

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 Timeline

• Study Start: 2014-03
• Status Verified: 2015-05
• Study First Submitted: 2015-05-19
• Study First Submitted QC: 2015-05-20
• Last Update Submitted: 2015-05-20
• Study First Posted: 2015-05-21
• Last Update Posted: 2015-05-21
• Primary Completion: 2015-10
• Study Completion: 2015-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• age > 18 years
• undergoing liver transplantation at Beaujon hospital (APHP, Clichy, France )

Exclusion Criteria

• age >70 years and <18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary dysfunction (PDF) of liver graft	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.

Secondary Outcome Measures

Name	Time	Method
Early graft function recovery.	First week	To study the relationship between alpha-GST levels in the plasma of the liver transplant recipient and early graft function recovery.

Trial Locations

Locations (1)

Réanimation hépato-digestive; 🇫🇷 Clichy, France