Computed Tomography Angiography Accuracy in Brain Death Diagnosis

July 18, 2019 updated by: Sergio Brasil, MD MSc
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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

106

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05403000
        • Hospital das Clínicas da Faculdade de Medicina da USP.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Individuals of any genre or age.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sergio Brasil, MD MSc

Collaborators

University of Sao Paulo

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

January 20, 2014

First Submitted That Met QC Criteria

January 22, 2014

First Posted (Estimate)

January 24, 2014

Study Record Updates

Last Update Posted (Actual)

July 23, 2019

Last Update Submitted That Met QC Criteria

July 18, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12500913400000068

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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