## Protocol Section
### Identification Module
**NCT ID:** NCT02695979

**Brief Title:** Changes of Macrophage Migration Inhibitory Factor During Orthotopic Liver Transplantation

**Official Title:** Changes of Macrophage Migration Inhibitory Factor and Thyroid Hormones During Liver Transplantation. Association With Graft Dysfunction

#### Organization Study ID Info
**ID:** 1458/2014
#### Organization
**Class:** OTHER
**Full Name:** Medical University of Vienna
### Status Module
#### Completion Date
**Date:** 2019-08

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** ACTIVE_NOT_RECRUITING
#### Last Update Post Date
**Date:** 2018-03-01

**Type:** ACTUAL

**Last Update Submit Date:** 2018-02-28

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2018-09

**Type:** ESTIMATED

#### Start Date
**Date:** 2014-08

**Status Verified Date:** 2018-02

#### Study First Post Date
**Date:** 2016-03-02
**Type:** ESTIMATED
**Study First Submit Date:** 2016-01-12
**Study First Submit QC Date:** 2016-02-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Medical University of Vienna

#### Responsible Party

**Investigator Affiliation:** Medical University of Vienna

**Investigator Full Name:** Dr. Joanna Stefaniak

**Investigator Title:** Dr.med.

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### 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.

### Conditions Module

**Conditions:**

- Evidence of Liver Transplantation

### Design Module

#### Bio Spec

**Description:** Blood, graft liver effluent, urine samples

**Retention:** SAMPLES_WITHOUT_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 100

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Label:** Patients undergoing OLT

### Outcomes Module

#### Other Outcomes

**Description:** Acute kidney injury, outcome

**Measure:** Acute kidney injury, outcome

**Time Frame:** 48 months

#### Primary Outcomes

**Measure:** Macrophage Migration Inhibitory Factor in human serum, liver graft effluent and urine

**Time Frame:** 24 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

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients undergoing orthotopic liver transplantation

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Vienna

**Country:** Austria

**Facility:** Medical University Vienna

**Zip:** 1090

#### Overall Officials

**Official 1:**

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

**Name:** Peter Faybik, Prof

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M16718

- Name: Thyroid Diseases

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Hemat

- Name: Hematinics

### Intervention Browse Module - Browse Leaves

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M11110

- Name: Liver Extracts

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
