Endothelial Glycocalyx Damage in Brain Death Organ Donors

Sponsor

University Hospital Hradec Kralove (Other)

Overall Status

Recruiting

CT.gov ID

NCT05609123

Collaborator

(none)

100

Enrollment

Location

29.9

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Damage Due to Hypoxia Organ Donors Organ Transplant Failure or Rejection	Diagnostic Test: Endothelial glycocalyx damage assessment

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Endothelial Glycocalyx Status and Damage in Brain Death Organ Donors

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Markers of endothelial glycocalyx damage [baseline at the time of inclusion]
Levels of syndecan-1 in serum and urine

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patients in critical condition declared as brain dead by clinical examination

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Hradec Kralove	Hradec Kralove		Czechia	50005

Sponsors and Collaborators

University Hospital Hradec Kralove

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

David Astapenko, MD, PhD, Deputy Head for Science and Research, University Hospital Hradec Kralove

ClinicalTrials.gov Identifier:

NCT05609123

Other Study ID Numbers:

CooperatioUK_DBD_GCX

First Posted:

Nov 8, 2022

Last Update Posted:

Nov 8, 2022

Last Verified:

Nov 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Brain Death

Brain Injuries

Hypoxia

Study Results

No Results Posted as of Nov 8, 2022