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Clinical Trials/NCT02045407
NCT02045407
Completed
Not Applicable

Computed Tomography Angiography Accuracy in Brain Death Diagnosis

Sergio Brasil, MD MSc1 site in 1 country106 target enrollmentStarted: January 2014Last updated:
ConditionsBrain Death

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Sergio Brasil, MD MSc
Enrollment
106
Locations
1
Primary Endpoint
Assess the presence or absence of contrast medium filling of the intracranial vessels in comatose patients.

Overview

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.

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
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Sex
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).

Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Sergio Brasil, MD MSc
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Sergio Brasil, MD MSc

MD

University of Sao Paulo

Study Sites (1)

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