NCT05609123

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
20mo left

Started Jan 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress72%
Jan 2022Dec 2027

Study Start

First participant enrolled

January 1, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 8, 2022

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

6 years

First QC Date

October 29, 2022

Last Update Submit

April 27, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Markers of endothelial glycocalyx damage

    Levels of syndecan-1 in serum and urine

    baseline at the time of inclusion

Study Arms (1)

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

Degradation products of endothelial glycocalyx will be assessed in the blood and urine.

Brain dead organ donors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Hradec Kralove

Hradec Králové, 50005, Czechia

RECRUITING

MeSH Terms

Conditions

Hypoxia, BrainRejection, Psychology

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypoxiaSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsSocial BehaviorBehavior

Central Study Contacts

David Astapenko, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Head for Science and Research

Study Record Dates

First Submitted

October 29, 2022

First Posted

November 8, 2022

Study Start

January 1, 2022

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

May 1, 2026

Record last verified: 2026-04

Locations