ClinicalTrials.gg
Sign In
RecruitingNCT05609123Updated May 1, 2026

Endothelial Glycocalyx Damage in Brain Death Organ Donors

An observational study in Brain Damage Due to Hypoxia, Organ Donors and Organ Transplant Failure or Rejection, sponsored by University Hospital Hradec Kralove. Recruiting at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-01.

Sponsored by University Hospital Hradec Kralove · Observational

From the registry’s dates

  • Started Jan 2022; still recruiting 4 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

Browse trials for

03

In context

Hypoxia, Brain

81 studies on the registry are indexed under Hypoxia, Brain; 19 are open to participants now.

This study's planned enrollment of 100 is above the median of 60 across 25 observational studies indexed under Hypoxia, Brain.

Browse Hypoxia, Brain studies →

Lead sponsor

University Hospital Hradec Kralove is the lead sponsor of 49 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • N/A
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testEndothelial glycocalyx damage assessment

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

06

What researchers measure

Primary outcomes

  1. Markers of endothelial glycocalyx damage

    Levels of syndecan-1 in serum and urine

    Time frame: baseline at the time of inclusion

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2022 (actual). Primary completion is estimated for Dec 2027, 71 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 29, 2022
First posted
Nov 8, 2022
StartActual
Jan 1, 2022
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 2027
Last update
May 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05609123
Lead sponsor
University Hospital Hradec Kralove
Responsible party
David Astapenko, MD, PhD, MBA (Deputy Head for Science and Research, University Hospital Hradec Kralove) — Principal investigator
First posted
Nov 8, 2022
Start date
Jan 1, 2022
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
May 1, 2026

Study contacts

David Astapenko, MD, PhD
Contact
david.astapenko@fnhk.cz
+420495833218

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hypoxia, Brain →

Other studies from this sponsor

University Hospital Hradec Kralove

Start the discussion