Computed Tomography Angiography to Brain Death Assessment

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by University of Sao Paulo
University of Sao Paulo
Information provided by (Responsible Party):
Sergio Brasil, University of Sao Paulo Identifier:
First received: January 20, 2014
Last updated: December 1, 2015
Last verified: December 2015
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.

Brain Death

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Computed Tomography Angiography to Brain Death Assessment

Resource links provided by NLM:

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Assess the presence or absence of contrast medium filling of the intracranial vessels in comatose patients. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.

Estimated Enrollment: 100
Study Start Date: November 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
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.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Individuals of any genre or age.

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:

  • Brain dead patients clinically confirmed.
  • Contraindications to the use of contrast medium (renal failure or allergy).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02045407

Contact: Sergio Brasil, MD 5511981210990

Hospital das Clínicas da Faculdade de Medicina da USP. Recruiting
São Paulo, Brazil, 05403000
Contact: Sergio Brasil, MD    5511981210990   
Sponsors and Collaborators
Sergio Brasil
University of Sao Paulo
Principal Investigator: Sergio Brasil, MD University of Sao Paulo
  More Information


Responsible Party: Sergio Brasil, MD, University of Sao Paulo Identifier: NCT02045407     History of Changes
Other Study ID Numbers: 12500913400000068 
Study First Received: January 20, 2014
Last Updated: December 1, 2015
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
Brain Death
Neurological Death
Cerebral circulatory arrest
Computed Tomography Angiography

Additional relevant MeSH terms:
Brain Death
Brain Diseases
Central Nervous System Diseases
Consciousness Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Pathologic Processes
Unconsciousness processed this record on April 27, 2016