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Completed

NCT Number: NCT04764266

Glycocalyx During Normothermic Machine Perfusion

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.

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Key information

Conditions

Glycocalyx Liver Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University Innsbruck, Department of Anesthesia and Intensive Care Medicine

Innsbruck, Tyrol, 6020, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. 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

  2. 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

  1. Syndecan 1 after transplantation

    Time frame: 72 hours

    Change of Syndecan 1 level after transplantation

  2. Heparansulfate level after transplantation

    Time frame: 72 hours

    Change of Syndecan 1 level after transplantation

Sponsors and collaborators

Lead sponsor

Medical University Innsbruck

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Feb 21, 2021
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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