NCT02695979

Brief Summary

Collecting blood, graft liver effluent and urine samples from patients undergoing orthotopic liver transplantation.

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 Aug 2014

Longer than P75 for all trials

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

August 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 2, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

March 1, 2018

Status Verified

February 1, 2018

Enrollment Period

4.1 years

First QC Date

January 12, 2016

Last Update Submit

February 28, 2018

Conditions

Evidence of Liver Transplantation

Outcome Measures

Primary Outcomes (1)

  • Macrophage Migration Inhibitory Factor in human serum, liver graft effluent and urine

    24 months

Other Outcomes (1)

  • Acute kidney injury, outcome

    48 months

Study Arms (1)

Patients undergoing OLT

Patients aged 18-70 with end-stage liver disease undergoing orthotopic liver transplantation (OLT).

Eligibility Criteria

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

Patients undergoing orthotopic liver transplantation

You may qualify if:

  • End stage liver disease, chronic liver failure, orthotopic liver transplantation

You may not qualify if:

  • Combined transplantations (liver plus kidney or lung), age under 18 y, acute liver failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Vienna

Vienna, 1090, Austria

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, graft liver effluent, urine samples

Study Officials

  • Peter Faybik, Prof

    Medical University Vienna, Department of Anesthesia, General Intensive Care and Pain Management

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.med.

Study Record Dates

First Submitted

January 12, 2016

First Posted

March 2, 2016

Study Start

August 1, 2014

Primary Completion

September 1, 2018

Study Completion

August 1, 2019

Last Updated

March 1, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)