Computed Tomography Angiography to Brain Death Assessment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02045407
Recruitment Status : Completed
First Posted : January 24, 2014
Last Update Posted : January 10, 2017
University of Sao Paulo
Information provided by (Responsible Party):
Sergio Brasil, University of Sao Paulo

Brief 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.

Condition or disease
Brain Death

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.

Study Type : Observational
Actual Enrollment : 91 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Computed Tomography Angiography to Brain Death Assessment
Study Start Date : January 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CT Scans
U.S. FDA Resources

Primary Outcome Measures :
  1. Assess the presence or absence of contrast medium filling of the intracranial vessels in comatose patients. [ Time Frame: 1 year ]
    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.

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02045407

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

Publications of Results:

Responsible Party: Sergio Brasil, MD, University of Sao Paulo Identifier: NCT02045407     History of Changes
Other Study ID Numbers: 12500913400000068
First Posted: January 24, 2014    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: January 2017

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

Additional relevant MeSH terms:
Brain Death
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations