Glycocalyx During Normothermic Machine Perfusion

Liver Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04764266
• Other study ID #: Glycocalyx during NMP
• Status: Completed
• Phase: N/A
• Start date: February 10, 2021
• Est. completion date: February 1, 2024

Study information

• Verified date: April 2022
• Source: Medical University Innsbruck
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glycocalyx
• Liver Transplantation

Intervention

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).

Locations

Country	Name	City	State
Austria	Medical University Innsbruck, Department of Anesthesia and Intensive Care Medicine	Innsbruck	Tirol

Sponsors (1)

Lead Sponsor	Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Syndecan 1 level during normothermic machine perfusion	Syndecan 1 level at the end of normothermic perfusion compared to the beginning of perfusion	24 hours
Primary	Heparansulfate level during normothermic machine perfusion	Heparansulfate level at the end of normothermic perfusion compared to the beginning of perfusion	24 hours
Secondary	Syndecan 1 after transplantation	Change of Syndecan 1 level after transplantation	72 hours
Secondary	Heparansulfate level after transplantation	Change of Syndecan 1 level after transplantation	72 hours