Brain DeathRBDDCNCT05903443
Research on the Brain Death Determination in China
An observational study of Brain Death and Electroencephalogram, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
Purpose China has a population of 1.4 billion and an enormous medical expenditure burden, and Chinese traditional culture has a long history. It takes time to recognize and accept the concept of brain death (BD) as death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Death, Electroencephalogram, Evoked Potential
- What is being tested?
- ancillary tests
- How many people
- 1,974 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 15 May 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
- No healthy volunteers
- Adult, Older adult
Study population: Coma cases registered by the National Brain Death Determination Quality Control Demonstration Hospital (BDQCH) in the BQCC/NHC from 2013 to 2019 were retrieved.
Who may be able to join
- All cases met the clinical criteria for BD, involving deep coma (Glasgow Coma Scale (GCS)=2T), the absence of brainstem reflexes (pupillary light reflex, corneal reflex, oculocephalogyric reflex, oculovestibular reflex, and cough reflex), and spontaneous respiration. Ancillary tests were completed for all patients.
Who cannot join
- Does not meet BD clinical evaluation criteria. Ancillary tests were not implemented.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Research on the Brain Death Determination and Quality Controlin Chinese Adults
Purpose China has a population of 1.4 billion and an enormous medical expenditure burden, and Chinese traditional culture has a long history. It takes time to recognize and accept the concept of brain death (BD) as death. Promoting brain death determination (BDD) and rationally allocating medical resources have become major national policy issues. To identify the safest and most reliable ancillary tests needed if the clinical examination is incomplete.
Method The technical group of the Brain Injury Evaluation Quality Control Center of the National Health Commission retrieved coma cases registered from 2013 to 2019. According to clinical criteria for Brain Death Determination (BDD), the patients were divided into two groups: a brain-death (BD) group and a non-BD group. The BD group was divided into a complete brain death with no doubt group (BD1 group) and an incomplete brain death with doubt group (BD2 group). Depending on the site of the brain injury, the accuracy of BDD was evaluated using the independent ancillary test or combined ancillary tests. Data from the BQCC/NHC database and yearbook were obtained, and data analysis and status comparison were conducted on six practical activities: organizational system construction, standard and specification formulation, case quality control, professional skills training, scientific research publicity and education, and international communication.
- Conditions
- Brain Death, Electroencephalogram, Evoked Potential, TCD, Quality Control
- Being tested
- ancillary tests
- Medical subject headings
- Brain Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ancillary testsDiagnostic test
electroencephalogram, short latency somatosensory evoked potential, transcranial Doppler
| Study group | Role | What they receive |
|---|---|---|
| BD group | All cases met the (brain death) BD clinical evaluation criteria, which were as follows: the cause of coma was known; exclusion of reversible coma; deep coma, Glasgow coma scale (GCS) = 2T; absence of five brain stem reflexes (pupillary light reflex, corneal reflex, oculocephalogyric reflex, oculovestibular reflex, and cough reflex); and no spontaneous respiration. Furthermore, according to whether the apnea test (AT) data were missing (implemented or completed), the patients were divided into the BD1 group (no AT missing group) and BD2 group (AT missing group). Receives: Diagnostic Test: ancillary tests | |
| non-BD group | All cases were from BDQCHs and fulfilled the criteria for coma (GCS of 3-5 points), but did not meet the clinical criteria for BD, such as retaining the brainstem reflex or having spontaneous respiration. For coma cases, all assessment items, specifications of technical operations, assessment steps, and evaluators were conducted in accordance with the requirements for BDD. Cases with coma were then submitted to the BQCC/NHC quality control system. Receives: Diagnostic Test: ancillary tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity
The sensitivity of BDD was evaluated using the independent ancillary test and combined ancillary tests
Measured: 1 month
specificity
The specificity of BDD was evaluated using the independent ancillary test and combined ancillary tests
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start1 Feb 2023
- Primary completion15 Apr 2023
- Study completion15 May 2023
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.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,974 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05903443
- Sponsor's protocol ID
- 2014004
- Acronym
- RBDDC
- Status last verified
- May 2023
- First submitted
- 24 May 2023
- Last updated
- 15 Jun 2023
- Results posted
- 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 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Brain Death Determination and Quality Controlin Chinese Adults
- ClinicalTrials.gov ID
- NCT05903443
- Acronym / sponsor ID
- RBDDC / 2014004
- Conditions
- Brain Death, Electroencephalogram, Evoked Potential, TCD, Quality Control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,974 participants (actual)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 15 Apr 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 15 Jun 2023 (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.
Purpose China has a population of 1.4 billion and an enormous medical expenditure burden, and Chinese traditional culture has a long history. It takes time to recognize and accept the concept of brain death (BD) as death. Promoting brain death determination (BDD) and rationally allocating medical resources have become major national policy issues. To identify the safest and most reliable ancillary tests needed if the clinical examination is incomplete.
Method The technical group of the Brain Injury Evaluation Quality Control Center of the National Health Commission retrieved coma cases registered from 2013 to 2019. According to clinical criteria for Brain Death Determination (BDD), the patients were divided into two groups: a brain-death (BD) group and a non-BD group. The BD group was divided into a complete brain death with no doubt group (BD1 group) and an incomplete brain death with doubt group (BD2 group). Depending on the site of the brain injury, the accuracy of BDD was evaluated using the independent ancillary test or combined ancillary tests. Data from the BQCC/NHC database and yearbook were obtained, and data analysis and status comparison were conducted on six practical activities: organizational system construction, standard and specification formulation, case quality control, professional skills training, scientific research publicity and education, and international communication.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BD group | – | Diagnostic Test: ancillary testsAll cases met the (brain death) BD clinical evaluation criteria, which were as follows: the cause of coma was known; exclusion of reversible coma; deep coma, Glasgow coma scale (GCS) = 2T; absence of five brain stem reflexes (pupillary light reflex, corneal reflex, oculocephalogyric reflex, oculovestibular reflex, and cough reflex); and no spontaneous respiration. Furthermore, according to whether the apnea test (AT) data were missing (implemented or completed), the patients were divided into the BD1 group (no AT missing group) and BD2 group (AT missing group). |
| non-BD group | – | Diagnostic Test: ancillary testsAll cases were from BDQCHs and fulfilled the criteria for coma (GCS of 3-5 points), but did not meet the clinical criteria for BD, such as retaining the brainstem reflex or having spontaneous respiration. For coma cases, all assessment items, specifications of technical operations, assessment steps, and evaluators were conducted in accordance with the requirements for BDD. Cases with coma were then submitted to the BQCC/NHC quality control system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Coma cases registered by the National Brain Death Determination Quality Control Demonstration Hospital (BDQCH) in the BQCC/NHC from 2013 to 2019 were retrieved.
Key inclusion criteria (1 listed)
- All cases met the clinical criteria for BD, involving deep coma (Glasgow Coma Scale (GCS)=2T), the absence of brainstem reflexes (pupillary light reflex, corneal reflex, oculocephalogyric reflex, oculovestibular reflex, and cough reflex), and spontaneous respiration. Ancillary tests were completed for all patients.
Key exclusion criteria (1 listed)
- Does not meet BD clinical evaluation criteria. Ancillary tests were not implemented.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ancillary testselectroencephalogram, short latency somatosensory evoked potential, transcranial Doppler | Diagnostic test | BD group, non-BD group |
Primary outcome
sensitivity
Time frame: 1 month
The sensitivity of BDD was evaluated using the independent ancillary test and combined ancillary tests
specificity
Time frame: 1 month
The specificity of BDD was evaluated using the independent ancillary test and combined ancillary tests
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Electroencephalogram, run by Xuanwu Hospital, Beijing at 1 site in China.
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 1 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: finished, as of the sponsor's last update on 15 Jun 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity (time frame: 1 month). The study lists 2 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 15 Jun 2023.