ClinicalTrials.gg
Status unknownNCT04914039Updated Jun 4, 2021

Evaluation of CTA on the Assessment of Brain Death

An observational study in Brain Death, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Status unknown at 1 site in China. Open to participants aged 12 Years to 72 Years. Per ClinicalTrials.gov, last updated 2021-06-04.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Observational

The sponsor has not verified this record recently (last verified May 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
63
Ages
12 Years to 72 Years
Sex
All
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Study 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. 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.

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Conditions studied

  • Brain Death

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Keywords

  • brain death
  • CT angiography
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In context

Brain Death

74 studies on the registry are indexed under Brain Death; 10 are open to participants now.

This study's planned enrollment of 63 is below the median of 80 across 33 observational studies indexed under Brain Death.

Browse Brain Death studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,047 studies on the registry; 502 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Years to 72 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

CTA imaging data of 63 patients with clinically suspected brain death

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Recruiting, no definite

Exclusion criteria

Exclusion Criteria:

  • Recruiting, no definite
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
63 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • CTA examination

    CTA examination group for suspected brain death

    Combination Product: Combination Product

  • Confirmed

    Confirmed group for brain death

    Other: NO CTA examination

Interventions

  • Combination productCombination Product

    Cases of brain death confirmed by the classic brain death confirmation test

  • OtherNO CTA examination

    NO CTA examination

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What researchers measure

Primary outcomes

  1. CTA used as an auxiliary diagnosis to determine brain death

    CTA used as an auxiliary diagnosis to determine brain death

    Time frame: through study completion, an average of 3 years.

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Study locations

1 of 1 sites recruiting
  • Brain Center, Second Affiliated Hospital, School of Medicine, Zhejiang University
    Hangzhou, Zhejiang 310009, China
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Feb 2021 (actual). Primary completion is estimated for Feb 2022, 12 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 1, 2021
First posted
Jun 4, 2021
StartActual
Feb 1, 2021
Primary completionEst.
Feb 1, 2022
CompletionEst.
Feb 1, 2023
Last update
Jun 4, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 4, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04914039
Responsible party
Sponsor
First posted
Jun 4, 2021
Start date
Feb 1, 2021
Primary completion
Feb 1, 2022 (estimated)
Completion
Feb 1, 2023 (estimated)
Last update
Jun 4, 2021

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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