Endothelial Glycocalyx Damage in Brain Death Organ Donors | NCT05609123

Studies
Endothelial Glycocalyx Damage in Brain Death Organ Donors

NCT05609123

Sponsor

University Hospital Hradec Kralove

Status

Recruiting

Last Update Posted

May 1, 2026Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Brain Damage Due to Hypoxia
Organ Donors
Organ Transplant Failure or Rejection

Interventions

Endothelial glycocalyx damage assessment

Countries

Czechia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2022Actual

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Oct 29, 2022

First Submission Date that Met QC Criteria

Nov 5, 2022

First Posted Date

Nov 8, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2026

Last Update Posted Date

May 1, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

David Astapenko, MD, PhD, MBA, Deputy Head for Science and Research, University Hospital Hradec KralovePrincipal Investigator

Lead Sponsor

University Hospital Hradec KraloveOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study aims the assessment of endothelial glycocalyx (EG) degradation in deceased organ donors. There is a lack of organs for the transplantation program. By the description of the EG status, we can open room for organ optimization before transplantation and improve the organ function after transplantation in marginal donors.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Brain dead organ donors		Patients with clinically proven bain death were assigned to the paraclinical confirmatory investigation of the brain death and subsequently accepted into the transplantation program.	Diagnostic Test: Endothelial glycocalyx damage assessment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endothelial glycocalyx damage assessment	Diagnostic Test	Degradation products of endothelial glycocalyx will be assessed in the blood and urine.	Brain dead organ donors

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Markers of endothelial glycocalyx damage	Levels of syndecan-1 in serum and urine	baseline at the time of inclusion

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients in critical condition declared as brain dead by clinical examination

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients in the intensive care unit with intracranial pathology are predisposed to brain death. In a time of confirmed brain death by clinical examination, the patients will be enrolled. Confirmatory paraclinical study of brain death is not mandatory for enrollment.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
David Astapenko, MD, PhD	Contact	+420495833218		david.astapenko@fnhk.cz

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Hradec Kralove	Recruiting	Hradec Králové		50005	Czechia

Condition Browse Module

MeSH Terms

ID	Term
D002534	Hypoxia, Brain
D012059	Rejection, Psychology

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D000860	Hypoxia

Browse Leaves

Not provided

Browse Branches

Not provided