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Computed Tomography Angiography to Brain Death Assessment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02045407
First Posted: January 24, 2014
Last Update Posted: January 10, 2017
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.
Collaborator:
University of Sao Paulo
Information provided by (Responsible Party):
Sergio Brasil, University of Sao Paulo
  Purpose
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
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 Sergio Brasil, 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 ]
    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.


Enrollment: 91
Study Start Date: January 2014
Study Completion Date: December 2016
Primary Completion Date: December 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.

  Eligibility

Information from the National Library of Medicine

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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.
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT02045407


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

Publications:

Responsible Party: Sergio Brasil, MD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02045407     History of Changes
Other Study ID Numbers: 12500913400000068
First Submitted: January 20, 2014
First Posted: January 24, 2014
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:
Death
Brain Death
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Coma
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations