Computed Tomography Angiography Accuracy in Brain Death Diagnosis

Sponsor
Sergio Brasil, MD MSc (Other)
Overall Status
Completed
CT.gov ID
NCT02045407
Collaborator
University of Sao Paulo (Other)
106
1
60
1.8

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    106 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Computed Tomography Angiography Accuracy in Brain Death Diagnosis
    Study Start Date :
    Jan 1, 2014
    Actual Primary Completion Date :
    Jan 1, 2018
    Actual Study Completion Date :
    Jan 1, 2019

    Outcome Measures

    Primary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Hospital das Clínicas da Faculdade de Medicina da USP. São Paulo Brazil 05403000

    Sponsors and Collaborators

    • Sergio Brasil, MD MSc
    • University of Sao Paulo

    Investigators

    • Principal Investigator: Sergio Brasil, MD, University of Sao Paulo

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sergio Brasil, MD MSc, MD, University of Sao Paulo
    ClinicalTrials.gov Identifier:
    NCT02045407
    Other Study ID Numbers:
    • 12500913400000068
    First Posted:
    Jan 24, 2014
    Last Update Posted:
    Jul 23, 2019
    Last Verified:
    Jul 1, 2019
    Keywords provided by Sergio Brasil, MD MSc, MD, University of Sao Paulo
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 23, 2019