## Protocol Section
### Identification Module
**NCT ID:** NCT06418165

**Acronym:** VIHOMPS

**Brief Title:** Vienna Hypothermic Oxygenated Machine Perfusion Study

**Official Title:** Vienna Hypothermic Oxygenated Machine Perfusion for Liver Transplantation Study

#### Organization Study ID Info
**ID:** 1610/2023
#### Organization
**Class:** OTHER
**Full Name:** Medical University of Vienna
### Status Module
#### Completion Date
**Date:** 2038-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2028-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2018-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Medical University of Vienna

#### Responsible Party

**Investigator Affiliation:** Medical University of Vienna

**Investigator Full Name:** David Pereyra

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** In this observational cohort study data on all patients undergoing liver transplantation after hypothermic oxygenated machine perfusion at Medical University of Vienna will be prospectively recorded. Investigation of short- and long-term outcome in this cohort will be conducted.

### Conditions Module

**Conditions:**

- End Stage Liver Disease

- Hepatocellular Carcinoma

**Keywords:**

- Liver Transplantation

- Hypothermic Oxygenated Machine Perfusion

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 500

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** Non-anastomotic stenosis, post-transplant cholangiopathy

**Measure:** Incidence of ischemic-type biliary lesions

**Time Frame:** Within one year after liver transplantation

#### Secondary Outcomes

**Description:** Deviation of bilirubin, transaminases or international normalised ratio

**Measure:** Rate of early allograft dysfunction

**Time Frame:** Evaluated within the first 7 postoperative days

**Measure:** Rate of primary non-function

**Time Frame:** Evaluated in the immediate postoperative period, specifically within the first postoperative week

**Measure:** Incidence of re-transplantation

**Time Frame:** Evaluated in the immediate postoperative period, specifically within the first postoperative week

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* patients undergoing liver transplantation with the use of hypothermic oxygenated machine perfusion
* age ≥ 18 years

Exclusion Criteria:

* pregnancy
* partial grafts
* the anatomical integrity of the liver is not preserved in a way that makes the perfusion of the liver possible

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients listed for and undergoing liver transplantation using a liver graft which was subjected to hypothermic oxygenated machine perfusion

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** david.pereyra@muv.ac.at

**Name:** David Pereyra, MD, PhD

**Phone:** +4314040056210

**Role:** CONTACT

**Contact 2:**

**Email:** jule.dingfelder@muv.ac.at

**Name:** Jule Dingfelder, MD

**Phone:** +4314040056210

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Vienna

**Contacts:**

***Contact 1:***

- **Email:** david.pereyra@muv.ac.at

- **Name:** David Pereyra, MD, PhD

- **Phone:** +4314040056210

- **Role:** CONTACT

***Contact 2:***

- **Email:** jule.dingfelder@muv.ac.at

- **Name:** Jule Dingfelder, MD

- **Phone:** +4314040056210

- **Role:** CONTACT

***Contact 3:***

- **Name:** Gabriela A Berlakovich, Prof, MD

- **Role:** SUB_INVESTIGATOR

***Contact 4:***

- **Name:** Georg Györi, MD

- **Role:** SUB_INVESTIGATOR

***Contact 5:***

- **Name:** Thomas Soliman, Prof, MD

- **Role:** SUB_INVESTIGATOR

***Contact 6:***

- **Name:** Andreas Salat, Prof, MD

- **Role:** SUB_INVESTIGATOR

***Contact 7:***

- **Name:** Gerd Silberhumer, Prof, MD

- **Role:** SUB_INVESTIGATOR

***Contact 8:***

- **Name:** Julia Jedamzik, MD

- **Role:** SUB_INVESTIGATOR

**Country:** Austria

**Facility:** Medical University of Vienna

**Status:** RECRUITING

**Zip:** 1090

#### Overall Officials

**Official 1:**

**Affiliation:** Medical University of Vienna, Division of Transplantation

**Name:** Gabriela A Berlakovich, Prof, MD

**Role:** STUDY_CHAIR

**Official 2:**

**Affiliation:** Medical University of Vienna, Division of Transplantation

**Name:** Georg Györi, MD

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Description:** data available upon reasonable request and in accordance with appropriate data sharing agreements

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000017093

- Term: Liver Failure

- ID: D000048550

- Term: Hepatic Insufficiency

- ID: D000001832

- Term: Body Temperature Changes

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M9613

- Name: Carcinoma, Hepatocellular

- Relevance: LOW

- As Found: Unknown

- ID: M29168

- Name: End Stage Liver Disease

- Relevance: HIGH

- As Found: End Stage Liver Disease

- ID: M11107

- Name: Liver Diseases

- Relevance: HIGH

- As Found: Liver Disease

- ID: M10085

- Name: Hypothermia

- Relevance: HIGH

- As Found: Hypothermic

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M19415

- Name: Liver Failure

- Relevance: LOW

- As Found: Unknown

- ID: M25970

- Name: Hepatic Insufficiency

- Relevance: LOW

- As Found: Unknown

- ID: M5111

- Name: Body Temperature Changes

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008107

- Term: Liver Diseases

- ID: D000058625

- Term: End Stage Liver Disease

- ID: D000007035

- Term: Hypothermia

### Intervention Browse Module - Browse Branches

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M11110

- Name: Liver Extracts

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
