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
• Status: Recruiting
• 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
• 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
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age =18 years

• organ donor

Exclusion Criteria:

• age under 18 years

Related Conditions & MeSH terms

• Brain Death
• Death
• Organ Donation

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