Methods of Confirmation of Brain Death

Use of Different Methods of Confirmation of Brain Death in Brain Death Donors

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.

Study Overview

• Status: Recruiting
• Conditions: Brain Death; Organ Donation

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Ondrej Hrdy, M.D.; Phone Number: +420 532233850; Email: hrdy.ondrej@fnbrno.cz
• Study Contact Backup: Name: Jaroslav Duba, M.D.; Phone Number: +420 532233850; Email: duba.jarosalv@fnbrno.cz

Study Locations

• Czechia
  • Brno, Czechia, 62500
    • Recruiting
    • University Hospital Brno
    • Contact: Ondrej Hrdy, M.D.; Phone Number: +420532233850; Email: hrdy.ondrej@fnbrno.cz
    • Contact: Jaroslav Duba, M.D.; Phone Number: +420532233850; Email: duba.jaroslav@fnbrno.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult critically ill patinets with confirmed brain death admitted to university hospital who become brain death organ donor.

Description

Inclusion Criteria:

• age ≥18 years
• organ donor

Exclusion Criteria:

• age under 18 years

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Brno University Hospital
• Investigators: Study Chair: Roman Gal, M.D., Ph.D., University Hospital Brno

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: January 26, 2021
• First Submitted That Met QC Criteria: January 29, 2021
• First Posted (Actual): February 2, 2021

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Unconsciousness; Consciousness Disorders; Coma; Death; Brain Death
• Other Study ID Numbers: CT0022020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No