GlycocalyxNCT04764266
Glycocalyx During Normothermic Machine Perfusion
A study testing Heparansulfate and Syndecan 1 in people with Glycocalyx and Liver Transplantation, run by Medical University Innsbruck at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glycocalyx, Liver Transplantation
- What is being tested?
- Heparansulfate and Syndecan 1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- 10 Feb 2021to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First deceased donor liver transplantation receiving a graft after normothermic machine perfusion
- Recipient age >18 years
- Written informed consent
Who cannot join
- Age < 18 years
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University Innsbruck, Department of Anesthesia and Intensive Care Medicine
Innsbruck, Tyrol, 6020
About this study
Official title: 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.
- Conditions
- Glycocalyx, Liver Transplantation
- Being tested
- Heparansulfate and Syndecan 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heparansulfate and Syndecan 1Diagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Heparansulfate and Syndecan 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Syndecan 1 level during normothermic machine perfusion
Syndecan 1 level at the end of normothermic perfusion compared to the beginning of perfusion
Measured: 24 hours
Heparansulfate level during normothermic machine perfusion
Heparansulfate level at the end of normothermic perfusion compared to the beginning of perfusion
Measured: 24 hours
Secondary outcomes (2)
Syndecan 1 after transplantation
Change of Syndecan 1 level after transplantation
Measured: 72 hours
Heparansulfate level after transplantation
Change of Syndecan 1 level after transplantation
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start10 Feb 2021
- Primary completion31 Dec 2023
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlycocalyxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Mathis, MD, Principal investigator, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04764266
- Sponsor's protocol ID
- Glycocalyx during NMP
- Status last verified
- Apr 2022
- First submitted
- 17 Feb 2021
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mathis S, Putzer G, Gasteiger L, Staier N, Schlosser L, Tscholl P, Breitkopf R, Cardini B, Kofler A, Oberhuber R, Resch T, Schneeberger S, Martini J. Effect of Normothermic Machine Perfusion on Glycocalyx Shedding During Liver Transplantation - A Prospective Pilot Study. Transpl Int. 2026 Mar 2;39:15502. doi: 10.3389/ti.2026.15502. eCollection 2026.
PubMed 41847595
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycocalyx Damage During Normothermic Graft Perfusion in Orthotopic Liver Transplantation - A Pilot Study
- ClinicalTrials.gov ID
- NCT04764266
- Acronym / sponsor ID
- Glycocalyx during NMP
- Conditions
- Glycocalyx, Liver Transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normothermic Machine Perfusion | Experimental | Diagnostic Test: Heparansulfate and Syndecan 1Blood sampling at 5 time points after transplantation Perfusate collection at 3 time points during normothermic machine perfusion prior to transplantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- First deceased donor liver transplantation receiving a graft after normothermic machine perfusion
- Recipient age >18 years
- Written informed consent
Key exclusion criteria (1 listed)
- Age < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heparansulfate and Syndecan 1Blood 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). | Diagnostic test | Normothermic Machine Perfusion |
Primary outcome
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
2 secondary outcomes
Syndecan 1 after transplantation
Time frame: 72 hours
Heparansulfate level after transplantation
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Derived from this study: PubMed 41847595Mathis S, Putzer G, Gasteiger L, Staier N, Schlosser L, Tscholl P, Breitkopf R, Cardini B, Kofler A, Oberhuber R, Resch T, Schneeberger S, Martini J. Effect of Normothermic Machine Perfusion on Glycocalyx Shedding During Liver Transplantation - A Prospective Pilot Study. Transpl Int. 2026 Mar 2;39:15502. doi: 10.3389/ti.2026.15502. eCollection 2026.
- Individual participant dataSharing planned: No
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Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Mathis, MD principal investigator
Medical University Innsbruck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heparansulfate and Syndecan 1 in people with Glycocalyx and Liver Transplantation, run by Medical University Innsbruck at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Syndecan 1 level during normothermic machine perfusion (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04764266, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.