Transcranial Doppler Ultrasonography and Brain Death

June 30, 2011 updated by: Institut d'Anesthesiologie des Alpes Maritimes

Evaluation of Transcranial Doppler Ultrasonography to Guide the Time of Cerebral Angiography for the Brain Death Diagnosis

In France the diagnosis of brain death relies on electroencephalography (EEG) or cerebral angiography. Concerning the latter a time of 6 hours is mandatory between the clinical diagnosis and the realization of the cerebral computed tomography (CT) angiography. Transcranial doppler (TCD) is not recommended in the french guidelines for the diagnosis of brain death. In other countries, some flow patterns allow to confirm the diagnosis of brain death. The hypothesis of our study is that TCD could shorten the time between the clinical diagnosis of brain death and the realization of the CT angiography.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

44

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

  • France
      • Nice, France, 06000
        • Centre Hospitalier Universitaire de Nice

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

ICU patients showing brain injury due to stroke or trauma and developping subsequently brain death

Description

Inclusion Criteria:

  • brain death patients

Exclusion Criteria:

  • craniectomy
  • post anoxia encephalopathy
  • no TCD performed before the clinical diagnosis of brain death
  • transtemporal approach impossible

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Usual
CT angiography is performed 6 hours after the clinical diagnosis of brain death.
TCD
When the diagnosis of brain death is made, TCD is performed and then every 2 hours until the flow patterns compatible with brain death are found. Then a CT angiography is performed.
Other: Transcranial doppler
A TCD is performed on all cerebral arteries (mean cerebral arteries, anterior cerebral arteries, basilar trunk, vertebral arteries and carotid arteries) until a flow pattern compatible with brain death is found

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time between clinical diagnosis of brain death and realization of CT angiography
Time Frame: the outcome is assessed when the CT angiography is performed
the outcome is assessed when the CT angiography is performed

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of CT angiography required for the diagnosis of brain death
Time Frame: the outcome is measured until the diagnosis of brain death is confirmed
the outcome is measured until the diagnosis of brain death is confirmed

Collaborators and Investigators

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

Sponsor

Institut d'Anesthesiologie des Alpes Maritimes

Investigators

  • Principal Investigator: Jean-Christophe Orban, MD, Nice University Hospital

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

February 1, 2009

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

February 12, 2010

First Submitted That Met QC Criteria

February 17, 2010

First Posted (Estimate)

February 18, 2010

Study Record Updates

Last Update Posted (Estimate)

July 4, 2011

Last Update Submitted That Met QC Criteria

June 30, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IAAM 2010-1

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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