Computed Tomography Angiography to Brain Death Assessment

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Sao Paulo
Sponsor:
Collaborator:
University of São Paulo, School of Medicine.
Information provided by (Responsible Party):
Sergio Brasil, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT02045407
First received: January 20, 2014
Last updated: January 22, 2014
Last verified: January 2014
  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 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 Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT02045407

Contacts
Contact: Sergio Brasil, MD 5511981210990 sbrasil@usp.br

Locations
Brazil
Hospital das Clínicas da Faculdade de Medicina da USP. Recruiting
São Paulo, Brazil, 05403000
Contact: Sergio Brasil, MD    5511981210990    sbrasil@usp.br   
Sponsors and Collaborators
Sergio Brasil
University of São Paulo, School of Medicine.
Investigators
Principal Investigator: Sergio Brasil, MD University of São Paulo, School of Medicine.
  More Information

Publications:

Responsible Party: Sergio Brasil, MD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02045407     History of Changes
Other Study ID Numbers: 12500913400000068
Study First Received: January 20, 2014
Last Updated: January 22, 2014
Health Authority: Brazil: Ethics Comittee

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

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

ClinicalTrials.gov processed this record on September 22, 2014