NCT02451046

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 19, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

May 21, 2015

Status Verified

May 1, 2015

Enrollment Period

1.6 years

First QC Date

May 19, 2015

Last Update Submit

May 20, 2015

Conditions

Keywords

Liver transplantationPrimary dysfunction

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Early graft function recovery.

    First week

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • age \>70 years and \<18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Réanimation hépato-digestive

Clichy, F-92210, France

RECRUITING

Study Officials

  • Catherine Paugam-Burtz, MD-PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine Paugam-Burtz, MD-PhD

CONTACT

Emmanuel Weiss, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 19, 2015

First Posted

May 21, 2015

Study Start

March 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

May 21, 2015

Record last verified: 2015-05

Locations