Brain Damage Due to HypoxiaNCT05609123
Endothelial Glycocalyx Damage in Brain Death Organ Donors
An observational study of Brain Damage Due to Hypoxia and Organ Donors, run by University Hospital Hradec Kralove at 1 site in Czechia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Damage Due to Hypoxia, Organ Donors, Organ Transplant Failure or Rejection
- What is being tested?
- Endothelial glycocalyx damage assessment
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jan 2022to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
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.
Who may be able to join
- patients in critical condition declared as brain dead by clinical examination
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Hradec Kralove
Hradec Králové, 50005
David Astapenko, MD, PhD, +420495833218, david.astapenko@fnhk.cz
About this study
Official title: 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.
- Being tested
- Endothelial glycocalyx damage assessment
- Medical subject headings
- Hypoxia, Brain, Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endothelial glycocalyx damage assessmentDiagnostic test
Degradation products of endothelial glycocalyx will be assessed in the blood and urine.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Endothelial glycocalyx damage assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Markers of endothelial glycocalyx damage
Levels of syndecan-1 in serum and urine
Measured: baseline at the time of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Damage Due to HypoxiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Hradec Kralove
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Astapenko, MD, PhD, MBA, University Hospital Hradec Kralove
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05609123
- Sponsor's protocol ID
- CooperatioUK_DBD_GCX
- Status last verified
- Apr 2026
- First submitted
- 29 Oct 2022
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Glycocalyx Status and Damage in Brain Death Organ Donors
- ClinicalTrials.gov ID
- NCT05609123
- Acronym / sponsor ID
- CooperatioUK_DBD_GCX
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital Hradec KraloveUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Nov 2022 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brain dead organ donors | – | Diagnostic Test: Endothelial glycocalyx damage assessmentPatients with clinically proven bain death were assigned to the paraclinical confirmatory investigation of the brain death and subsequently accepted into the transplantation program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (1 listed)
- patients in critical condition declared as brain dead by clinical examination
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Endothelial glycocalyx damage assessmentDegradation products of endothelial glycocalyx will be assessed in the blood and urine. | Diagnostic test | Brain dead organ donors |
Primary outcome
Markers of endothelial glycocalyx damage
Time frame: baseline at the time of inclusion
Levels of syndecan-1 in serum and urine
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Damage Due to Hypoxia and Organ Donors, run by University Hospital Hradec Kralove at 1 site in Czechia.
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 1 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: looking for participants now, as of the sponsor's last update on 1 May 2026. 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 Czechia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Astapenko, MD, PhD (+420495833218, david.astapenko@fnhk.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Markers of endothelial glycocalyx damage (time frame: baseline at the time of inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2026.