Changes of Macrophage Migration Inhibitory Factor During... | NCT02695979

Studies
Changes of Macrophage Migration Inhibitory Factor During Orthotopic Liver Transplantation

NCT02695979

Sponsor

Medical University of Vienna

Status

Unknown status

Last Update Posted

Mar 1, 2018Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Evidence of Liver Transplantation

Interventions

Not provided

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2014

Primary Completion Date

Sep 2018Estimated

Completion Date

Aug 2019Estimated

First Submitted Date

Jan 12, 2016

First Submission Date that Met QC Criteria

Feb 24, 2016

First Posted Date

Mar 2, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2018

Last Update Posted Date

Mar 1, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Aims are to measure Macrophage Migration Inhibitory Factor, Macrophage Migration Inhibitory Factor II and its' soluble receptor CD74 in serum, liver graft effluent and urine in and evaluate MIF's role in hepatic ischemia/reperfusion injury, postoperative graft function and kidney function.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients undergoing OLT		Patients aged 18-70 with end-stage liver disease undergoing orthotopic liver transplantation (OLT).

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Macrophage Migration Inhibitory Factor in human serum, liver graft effluent and urine		24 months

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
Acute kidney injury, outcome	Acute kidney injury, outcome	48 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing orthotopic liver transplantation

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter Faybik, Prof	Medical University Vienna, Department of Anesthesia, General Intensive Care and Pain Management	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University Vienna		Vienna		1090	Austria

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided