Endothelial Glycocalyx Damage in Brain Death Organ Donors

Endothelial Glycocalyx Status and Damage in Brain Death Organ Donors

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.

Study Overview

• Status: Recruiting
• Conditions: Organ Transplant Failure or Rejection; Brain Damage Due to Hypoxia; Organ Donors
• Intervention / Treatment: Diagnostic test: Endothelial glycocalyx damage assessment

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: David Astapenko, MD, PhD; Phone Number: +420495833218; Email: david.astapenko@fnhk.cz

Study Locations

• Czechia
  • Hradec Králové, Czechia, 50005
    • Recruiting
    • University hospital Hradec Králové
    • Contact: David Astapenko, MD, PhD; Phone Number: +420495833218; Email: david.astapenko@fnhk.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• patients in critical condition declared as brain dead by clinical examination

Exclusion Criteria:

• N/A

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Degradation products of endothelial glycocalyx will be assessed in the blood and urine.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital Hradec Kralove

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: October 29, 2022
• First Submitted That Met QC Criteria: November 5, 2022
• First Posted (Actual): November 8, 2022

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms, Respiratory; Hypoxia; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Social Behavior; Hypoxia, Brain; Rejection, Psychology
• Other Study ID Numbers: CooperatioUK_DBD_GCX

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No