Glycocalyx During Normothermic Machine Perfusion

Glycocalyx Damage During Normothermic Graft Perfusion in Orthotopic Liver Transplantation - A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Liver Transplantation; Glycocalyx
• Intervention / Treatment: Diagnostic test: Heparansulfate and Syndecan 1

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Simon Mathis, MD; Phone Number: 004350482139; Email: simon.mathis@i-med.ac.at

Study Locations

• Austria
  • Tirol
    • Innsbruck, Tirol, Austria, 6020
      • Medical University Innsbruck, Department of Anesthesia and Intensive Care Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Age < 18 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Normothermic Machine Perfusion; 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; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Syndecan 1 after transplantation	Change of Syndecan 1 level after transplantation	72 hours
Heparansulfate level after transplantation	Change of Syndecan 1 level after transplantation	72 hours

Collaborators and Investigators

• Sponsor: Medical University Innsbruck
• Investigators: Principal Investigator: Simon Mathis, MD, Medical University Innsbruck

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2021
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: February 17, 2021
• First Submitted That Met QC Criteria: February 17, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: Glycocalyx during NMP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No