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Clinical Trials/NCT04764266
NCT04764266CompletedNot Applicable

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

Medical University Innsbruck2 sites in 1 country30 target enrollmentStarted: February 10, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
30
Locations
2
Primary Endpoint
Syndecan 1 level during normothermic machine perfusion

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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

Intervention: Heparansulfate and Syndecan 1 (Diagnostic Test)

Outcomes

Primary Outcomes

Syndecan 1 level during normothermic machine perfusion

Time Frame: 24 hours

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

Heparansulfate level during normothermic machine perfusion

Time Frame: 24 hours

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

Secondary Outcomes

  • Syndecan 1 after transplantation(72 hours)
  • Heparansulfate level after transplantation(72 hours)

Investigators

Sponsor
Medical University Innsbruck
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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