Brain DeathNCT04914039
Evaluation of CTA on the Assessment of Brain Death
An observational study of Brain Death, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
At present, different countries have different standards for the diagnosis of brain death, but according to the classic brain death confirmation test, it needs to be combined with transcranial Doppler, EEG, evoked potential and apnea test in clinical practice. Read more about this study
- Who is it for?
- Ages 12 to 72 years
- Conditions the study is for
- Brain Death
- What is being tested?
- Combination Product and NO CTA examination
- How many people
- 63 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2021to 1 Feb 2023
- How long will I take part?
- 1 Year
- 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 12 to 72 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: CTA imaging data of 63 patients with clinically suspected brain death
Who may be able to join
- Recruiting, no definite
Who cannot join
- Recruiting, no definite
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Brain Center, Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
Peng XU, +86 18758276628, xupeng@zju.edu.cn
About this study
At present, different countries have different standards for the diagnosis of brain death, but according to the classic brain death confirmation test, it needs to be combined with transcranial Doppler, EEG, evoked potential and apnea test in clinical practice. Some patients cannot undergo a complete clinical examination and apnea test due to certain factors, and the determination of brain death is limited. The American Academy of Neurology (AAN) guidelines regard cerebral angiography as an acceptable auxiliary examination and is widely regarded as the gold standard for cerebral blood flow evaluation. CT cerebrovascular angiography (CTA) is a noninvasive and widely used examination method that can identify missing or severely reduced cerebral blood flow. However, due to limited experience and lack of sufficient evidence to prove its reliability, it is not included in the AAN A recognized auxiliary examination; there are also a large number of domestic and foreign literature reports that CTA can be used as a new confirmation test for clinical judgment of brain death.
This study aims to explore the value of CTA in the judgment of patients with brain death.
- Conditions
- Brain Death
- Being tested
- Combination Product, NO CTA examination
- Keywords
- brain death, CT angiography
- Medical subject headings
- Brain Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination ProductCombination product
Cases of brain death confirmed by the classic brain death confirmation test
NO CTA examinationOther
NO CTA examination
| Study group | Role | What they receive |
|---|---|---|
| CTA examination | CTA examination group for suspected brain death Receives: Combination Product: Combination Product | |
| Confirmed | Confirmed group for brain death Receives: Other: NO CTA examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
CTA used as an auxiliary diagnosis to determine brain death
CTA used as an auxiliary diagnosis to determine brain death
Measured: through study completion, an average of 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start1 Feb 2021
- Primary completion1 Feb 2022 (estimated)
- Study completion1 Feb 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.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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 only
- Time perspective
- Prospective
- Enrolment
- 63 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04914039
- Sponsor's protocol ID
- 2020-031
- Status last verified
- May 2021
- First submitted
- 1 Jun 2021
- Last updated
- 4 Jun 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of CTA on the Assessment of Brain Death
- ClinicalTrials.gov ID
- NCT04914039
- Acronym / sponsor ID
- 2020-031
- Conditions
- Brain Death
- Keywords
- brain death, CT angiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 4 Jun 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.
At present, different countries have different standards for the diagnosis of brain death, but according to the classic brain death confirmation test, it needs to be combined with transcranial Doppler, EEG, evoked potential and apnea test in clinical practice. Some patients cannot undergo a complete clinical examination and apnea test due to certain factors, and the determination of brain death is limited. The American Academy of Neurology (AAN) guidelines regard cerebral angiography as an acceptable auxiliary examination and is widely regarded as the gold standard for cerebral blood flow evaluation. CT cerebrovascular angiography (CTA) is a noninvasive and widely used examination method that can identify missing or severely reduced cerebral blood flow. However, due to limited experience and lack of sufficient evidence to prove its reliability, it is not included in the AAN A recognized auxiliary examination; there are also a large number of domestic and foreign literature reports that CTA can be used as a new confirmation test for clinical judgment of brain death.
This study aims to explore the value of CTA in the judgment of patients with brain death.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTA examination | – | Combination Product: Combination ProductCTA examination group for suspected brain death |
| Confirmed | – | Other: NO CTA examinationConfirmed group for brain death |
Who may qualify
- Ages
- 12 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- CTA imaging data of 63 patients with clinically suspected brain death
Key inclusion criteria (1 listed)
- Recruiting, no definite
Key exclusion criteria (1 listed)
- Recruiting, no definite
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 |
|---|---|---|
| Combination ProductCases of brain death confirmed by the classic brain death confirmation test | Combination product | CTA examination |
| NO CTA examinationNO CTA examination | Other | Confirmed |
Primary outcome
CTA used as an auxiliary diagnosis to determine brain death
Time frame: through study completion, an average of 3 years.
CTA used as an auxiliary diagnosis to determine brain death
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
- Individual participant dataSharing planned: Undecided
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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.
Brain Center, Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, China
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, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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: status not confirmed, as of the sponsor's last update on 4 Jun 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CTA used as an auxiliary diagnosis to determine brain death (time frame: through study completion, an average of 3 years.). 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 4 Jun 2021.