ClinicalTrials.gg
CompletedNCT02045407Updated Jul 23, 2019

Computed Tomography Angiography Accuracy in Brain Death Diagnosis

An observational study in Brain Death, sponsored by Sergio Brasil, MD MSc. Completed at 1 site in Brazil. Per ClinicalTrials.gov, last updated 2019-07-23.

Sponsored by Sergio Brasil, MD MSc · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
106
Sex
All
01

Study summary

The purpose of this study is to assess the reliability of computed tomography angiography (CTA) to diagnose brain death, face of several conditions that make impossible to define such diagnosis using clinical criteria exclusively.

Read the detailed description

Critically ill patients, presenting Glasgow Coma Score 5 or lower, will be submitted to the Computed Tomography Angiography (CTA) of the skull assessment, and follow a clinical evaluation for brain death, additionally, transcranial Doppler would be applied as the gold standard for brain death.

We will exclude patients whose do not can be submitted to contrast injection, or if a brain death clinical evaluation has been performed prior the CTA.

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Conditions studied

  • Brain Death

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Keywords

  • Brain Death
  • Neurological Death
  • Cerebral circulatory arrest
  • Computed Tomography 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 enrollment of 106 is above the median of 80 across 33 observational studies indexed under Brain Death.

Browse Brain Death studies →

Lead sponsor

This is the only study on the registry with Sergio Brasil, MD MSc as lead sponsor.

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

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Individuals of any genre or age.

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

  • Individuals of any age or sex with brain death suspicion raised, before clinical test.
  • Comatose patients presenting Glasgow Coma Score as or under 5 points, under sedative agents or not.

Exclusion criteria

Exclusion Criteria:

  • Brain dead patients clinically confirmed.
  • to the use of contrast medium (renal failure or allergy).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
106 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Assess the presence or absence of contrast medium filling of the intracranial vessels in comatose patients.

    After excluding confounding factors, we will submit comatose patients to CTA. Immediately after the exam, we will perform clinical evaluation for brain death and calculate CTA sensibility and specificity for this diagnosis. Time between these two interventions will be measured.

    Time frame: 1 year

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Study locations

1 site
  • Hospital das Clínicas da Faculdade de Medicina da USP.
    São Paulo, 05403000, Brazil
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References and documents

Publications

  • Welschehold S, Kerz T, Boor S, Reuland K, Thomke F, Reuland A, Beyer C, Tschan C, Wagner W, Muller-Forell W, Giese A. Computed tomographic angiography as a useful adjunct in the diagnosis of brain death. J Trauma Acute Care Surg. 2013 May;74(5):1279-85. doi: 10.1097/TA.0b013e31828c46ba. PubMed 23609279 ↗
  • Welschehold S, Kerz T, Boor S, Reuland K, Thomke F, Reuland A, Beyer C, Wagner W, Muller-Forell W, Giese A. Detection of intracranial circulatory arrest in brain death using cranial CT-angiography. Eur J Neurol. 2013 Jan;20(1):173-9. doi: 10.1111/j.1468-1331.2012.03826.x. Epub 2012 Jul 12. PubMed 22788547 ↗
  • Rieke A, Regli B, Mattle HP, Brekenfeld C, Gralla J, Schroth G, Ozdoba C. Computed tomography angiography (CTA) to prove circulatory arrest for the diagnosis of brain death in the context of organ transplantation. Swiss Med Wkly. 2011 Oct 4;141:w13261. doi: 10.4414/smw.2011.13261. eCollection 2011. PubMed 21971739 ↗
  • Bohatyrewicz R, Sawicki M, Walecka A, Walecki J, Rowinski O, Bohatyrewicz A, Kanski A, Czajkowski Z, Krzysztalowski A, Solek-Pastuszka J, Zukowski M, Marzec-Lewenstein E, Wojtaszek M. Computed tomographic angiography and perfusion in the diagnosis of brain death. Transplant Proc. 2010 Dec;42(10):3941-6. doi: 10.1016/j.transproceed.2010.09.143. Erratum In: Transplant Proc. 2011 Mar;43(2):668. Kanski, A [added]. PubMed 21168593 ↗
  • Berenguer CM, Davis FE, Howington JU. Brain death confirmation: comparison of computed tomographic angiography with nuclear medicine perfusion scan. J Trauma. 2010 Mar;68(3):553-9. doi: 10.1097/TA.0b013e3181cef18a. PubMed 20220416 ↗
  • Escudero D, Otero J, Marques L, Parra D, Gonzalo JA, Albaiceta GM, Cofino L, Blanco A, Vega P, Murias E, Meilan A, Roger RL, Taboada F. Diagnosing brain death by CT perfusion and multislice CT angiography. Neurocrit Care. 2009;11(2):261-71. doi: 10.1007/s12028-009-9243-7. Epub 2009 Jun 30. PubMed 19565357 ↗
  • Frampas E, Videcoq M, de Kerviler E, Ricolfi F, Kuoch V, Mourey F, Tenaillon A, Dupas B. CT angiography for brain death diagnosis. AJNR Am J Neuroradiol. 2009 Sep;30(8):1566-70. doi: 10.3174/ajnr.A1614. Epub 2009 Apr 30. PubMed 19406767 ↗
  • Dupas B, Gayet-Delacroix M, Villers D, Antonioli D, Veccherini MF, Soulillou JP. Diagnosis of brain death using two-phase spiral CT. AJNR Am J Neuroradiol. 1998 Apr;19(4):641-7. PubMed 9576648 ↗
  • Leclerc X, Taschner CA, Vidal A, Strecker G, Savage J, Gauvrit JY, Pruvo JP. The role of spiral CT for the assessment of the intracranial circulation in suspected brain-death. J Neuroradiol. 2006 Apr;33(2):90-5. doi: 10.1016/s0150-9861(06)77237-6. PubMed 16733422 ↗
  • Combes JC, Chomel A, Ricolfi F, d'Athis P, Freysz M. Reliability of computed tomographic angiography in the diagnosis of brain death. Transplant Proc. 2007 Jan-Feb;39(1):16-20. doi: 10.1016/j.transproceed.2006.10.204. PubMed 17275466 ↗
  • Quesnel C, Fulgencio JP, Adrie C, Marro B, Payen L, Lembert N, El Metaoua S, Bonnet F. Limitations of computed tomographic angiography in the diagnosis of brain death. Intensive Care Med. 2007 Dec;33(12):2129-35. doi: 10.1007/s00134-007-0789-6. Epub 2007 Jul 21. PubMed 17643226 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2014, a primary completion of Jan 2018 and a completion of Jan 2019. It does not say whether these dates are actual or estimated.

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

Registered
Jan 20, 2014
First posted
Jan 24, 2014
Start
Jan 2014
Primary completionActual
Jan 2018
CompletionActual
Jan 2019
Last update
Jul 23, 2019
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 Jul 23, 2019, 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
NCT02045407
Lead sponsor
Sergio Brasil, MD MSc
Responsible party
Sergio Brasil, MD MSc (MD, University of Sao Paulo) — Sponsor-investigator
First posted
Jan 24, 2014
Start date
Jan 2014
Primary completion
Jan 2018
Completion
Jan 2019
Last update
Jul 23, 2019

Study contacts

Sergio Brasil, MD
principal investigator · University of Sao Paulo

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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