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Glycocalyx During Normothermic Machine Perfusion

Sponsor
Medical University Innsbruck (Other)
Overall Status
Recruiting
CT.gov ID
NCT04764266
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
22.6
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Heparansulfate and Syndecan 1
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Glycocalyx Damage During Normothermic Graft Perfusion in Orthotopic Liver Transplantation - A Pilot Study
Actual Study Start Date :
Feb 10, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

  1. Syndecan 1 level during normothermic machine perfusion [24 hours]

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

  2. Heparansulfate level during normothermic machine perfusion [24 hours]

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

Secondary Outcome Measures

  1. Syndecan 1 after transplantation [72 hours]

    Change of Syndecan 1 level after transplantation

  2. Heparansulfate level after transplantation [72 hours]

    Change of Syndecan 1 level after transplantation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University Innsbruck, Department of Anesthesia and Intensive Care Medicine Innsbruck Tirol Austria 6020

Sponsors and Collaborators

  • Medical University Innsbruck

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Medical University Innsbruck
ClinicalTrials.gov Identifier:
NCT04764266
Other Study ID Numbers:
  • Glycocalyx during NMP
First Posted:
Feb 21, 2021
Last Update Posted:
Apr 6, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 6, 2022