Computed Tomography Angiography Accuracy in Brain Death Diagnosis

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.

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Key information

Conditions

Brain Death Brain Diseases Central Nervous System Diseases Coma Consciousness Disorders Death Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Unconsciousness

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital das Clínicas da Faculdade de Medicina da USP.

São Paulo, 05403000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Sergio Brasil, MD MSc

Other

Collaborators

University of Sao Paulo

Registry information

Important dates

Study start: 2014
Primary completion: 2018
Study completion: 2019
First posted: Jan 24, 2014
Registry last updated: Jul 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed