Brain DeathNCT04734574
Methods of Confirmation of Brain Death
An observational study of Brain Death and Organ Donation, run by Brno University Hospital at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Death, Organ Donation
- How many people
- 60 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Apr 2022to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: Adult critically ill patinets with confirmed brain death admitted to university hospital who become brain death organ donor.
Who may be able to join
- age ≥18 years
- organ donor
Who cannot join
- age under 18 years
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Brno
Brno, 62500
Ondrej Hrdy, M.D., +420532233850, hrdy.ondrej@fnbrno.cz
Jaroslav Duba, M.D., +420532233850, duba.jaroslav@fnbrno.cz
About this study
Official title: 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.
Read the 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.
- Conditions
- Brain Death, Organ Donation
- Medical subject headings
- Brain Death
What is being measured
The primary outcome is the main question the study is designed to answer.
Angiography
Cerebral panangiography
Measured: within 24 hours after the onset of signs of brain death
Brainstem auditory evoked potentials
Brainstem auditory evoked potentials
Measured: within 24 hours after the onset of signs of brain death
Brain scintigraphy
Brain scintigraphy
Measured: within 24 hours after the onset of signs of brain death
Cerebral computed tomography angiography
Cerebral computed tomography angiography
Measured: within 24 hours after the onset of signs of brain death
Transcranial Doppler ultrasonography
Transcranial Doppler ultrasonography
Measured: within 24 hours after the onset of signs of brain death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start1 Apr 2022
- Primary completion1 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain DeathStudies 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
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ondrej Hrdy, Brno University Hospital
- Investigators
- Roman Gal, M.D., Ph.D., Study chair, Brno University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734574
- Sponsor's protocol ID
- CT0022020
- Status last verified
- Mar 2023
- First submitted
- 26 Jan 2021
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Different Methods of Confirmation of Brain Death in Brain Death Donors
- ClinicalTrials.gov ID
- NCT04734574
- Acronym / sponsor ID
- CT0022020
- Conditions
- Brain Death, Organ Donation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 2 Feb 2021 (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 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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult critically ill patinets with confirmed brain death admitted to university hospital who become brain death organ donor.
Key inclusion criteria (2 listed)
- age ≥18 years
- organ donor
Key exclusion criteria (1 listed)
- age under 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Angiography
Time frame: within 24 hours after the onset of signs of brain death
Cerebral panangiography
Brainstem auditory evoked potentials
Time frame: within 24 hours after the onset of signs of brain death
Brainstem auditory evoked potentials
Brain scintigraphy
Time frame: within 24 hours after the onset of signs of brain death
Brain scintigraphy
Cerebral computed tomography angiography
Time frame: within 24 hours after the onset of signs of brain death
Cerebral computed tomography angiography
Transcranial Doppler ultrasonography
Time frame: within 24 hours after the onset of signs of brain death
Transcranial Doppler ultrasonography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Roman Gal, M.D., Ph.D. study chair
Brno University Hospital
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 Death and Organ Donation, run by Brno University Hospital 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 2 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: status not confirmed, as of the sponsor's last update on 28 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ondrej Hrdy, M.D. (532233850 ext. +420, hrdy.ondrej@fnbrno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Angiography (time frame: within 24 hours after the onset of signs of brain death). The study lists 5 primary outcomes in all. 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 28 Mar 2023.