Glycocalyx During Normothermic Machine Perfusion

NCT04764266 | Completed

• 1 other identifier: Glycocalyx during NMP
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

An organ intended for transplantation is normally stored on ice (cold storage, CS) after explantation from the donor. During this storage process, damage to the endothelial glycocalyx occurs. It is known from numerous studies that the integrity of the endothelial glycocalyx is necessary for organ function. Normothermic machine perfusion is an alternative storage method for explanted livers, where the graft is perfused with warm blood. This study aims to clarify the influence of normothermic machine perfusion on endothelial glycocalyx damage of the graft.

Conditions

Glycocalyx; Liver Transplantation

Outcome Measures

Primary Outcomes (2)

• Syndecan 1 level during normothermic machine perfusion

  Syndecan 1 level at the end of normothermic perfusion compared to the beginning of perfusion

  24 hours

• Heparansulfate level during normothermic machine perfusion

  Heparansulfate level at the end of normothermic perfusion compared to the beginning of perfusion

  24 hours

Secondary Outcomes (2)

• Syndecan 1 after transplantation

  72 hours

• Heparansulfate level after transplantation

  72 hours

Study Arms (1)

Normothermic Machine Perfusion

EXPERIMENTAL

Blood sampling at 5 time points after transplantation Perfusate collection at 3 time points during normothermic machine perfusion prior to transplantation

Diagnostic Test: Heparansulfate and Syndecan 1

Interventions

Heparansulfate and Syndecan 1 DIAGNOSTIC_TEST

Blood samples will be collected from the patient at 5 different time points. Three perfusate samples will be collected during normothermic machine perfusion (4,9ml each).

Normothermic Machine Perfusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First deceased donor liver transplantation receiving a graft after normothermic machine perfusion
• Recipient age \>18 years
• Written informed consent

You may not qualify if:

• Age \< 18 years

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

Medical University Innsbruck, Department of Anesthesia and Intensive Care Medicine

Innsbruck, Tyrol, 6020, Austria

Location

Study Officials

• Simon Mathis, MD

  Medical University Innsbruck

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: February 21, 2021
• Study Start: February 10, 2021
• Primary Completion: December 31, 2023
• Study Completion: February 1, 2024
• Last Updated: March 13, 2024

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)