Usefulness of Alpha-GST in Liver Transplantation

NCT ID: NCT02451046

Last Updated: 2015-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-10-31

Brief Summary

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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

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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.

Conditions

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Evidence of Liver Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* age \>70 years and \<18 years
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beaujon Hospital

OTHER

Sponsor Role lead

Responsible Party

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Paugam-Burtz

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Catherine Paugam-Burtz, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Réanimation hépato-digestive

Clichy, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Catherine Paugam-Burtz, MD-PhD

Role: CONTACT

140875610 ext. +33

Emmanuel Weiss, MD

Role: CONTACT

603004193 ext. +33

Facility Contacts

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Catherine Paugam-Burtz, MD-PhD

Role: primary

140875610 ext. +33

Emmanuel Weiss, MD

Role: backup

603004193 ext. +33

Other Identifiers

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2015-A00839-40

Identifier Type: -

Identifier Source: org_study_id

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