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NCT04734574 Clinical Trial

Methods of Confirmation of Brain Death

Brain Death Clinical Trial

Official title:
Use of Different Methods of Confirmation of Brain Death in Brain Death Donors

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04734574
Other study ID # CT0022020
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2022
Est. completion date December 30, 2023

Study information
Verified date March 2023
Source Brno University Hospital
Contact Ondrej Hrdy, M.D.
Phone 532233850
Email hrdy.ondrej@fnbrno.cz
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to describe the use of methods confirming brain death in the real clinical practice of the transplant program in the Czech Republic.

Description:

Organ donation is possible in the Czech Republic only after meeting the legislative requirements. These require confirmation of brain death by one of the statutory methods before organ harvesting. The use of these methods in clinical practice has not yet been described.The aim of this retrospective observational study is to describe the use of these methods in the real clinical practice of the transplant program in the Czech Republic, taking into account the legislation of other European countries.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date December 30, 2023
Est. primary completion date December 1, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - age =18 years - organ donor Exclusion Criteria: - age under 18 years

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Czechia University Hospital Brno Brno

Sponsors (1)
Lead Sponsor Collaborator
Brno University Hospital

Country where clinical trial is conducted

Czechia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Angiography Cerebral panangiography within 24 hours after the onset of signs of brain death
Primary Brainstem auditory evoked potentials Brainstem auditory evoked potentials within 24 hours after the onset of signs of brain death
Primary Brain scintigraphy Brain scintigraphy within 24 hours after the onset of signs of brain death
Primary Cerebral computed tomography angiography Cerebral computed tomography angiography within 24 hours after the onset of signs of brain death
Primary Transcranial Doppler ultrasonography Transcranial Doppler ultrasonography within 24 hours after the onset of signs of brain death
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