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Transcranial Doppler Ultrasonography and Brain Death

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ClinicalTrials.gov Identifier: NCT01070563
Recruitment Status : Completed
First Posted : February 18, 2010
Last Update Posted : July 4, 2011
Sponsor:
Information provided by:
Institut d'Anesthesiologie des Alpes Maritimes

Brief Summary:
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.

Condition or disease Intervention/treatment
Brain Dead Other: Transcranial doppler

Study Type : Observational
Estimated Enrollment : 44 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Evaluation of Transcranial Doppler Ultrasonography to Guide the Time of Cerebral Angiography for the Brain Death Diagnosis
Study Start Date : February 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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




Primary Outcome Measures :
  1. Time between clinical diagnosis of brain death and realization of CT angiography [ Time Frame: the outcome is assessed when the CT angiography is performed ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
ICU patients showing brain injury due to stroke or trauma and developping subsequently brain death
Criteria

Inclusion Criteria:

  • brain death patients

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01070563


Locations
France
Centre Hospitalier Universitaire de Nice
Nice, France, 06000
Sponsors and Collaborators
Institut d'Anesthesiologie des Alpes Maritimes
Investigators
Principal Investigator: Jean-Christophe Orban, MD Nice University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Orban Jean-Christophe, MD, Nice University Hospital
ClinicalTrials.gov Identifier: NCT01070563     History of Changes
Other Study ID Numbers: IAAM 2010-1
First Posted: February 18, 2010    Key Record Dates
Last Update Posted: July 4, 2011
Last Verified: June 2011

Keywords provided by Institut d'Anesthesiologie des Alpes Maritimes:
Brain death
CT angiography
Ultrasonography, doppler, transcranial

Additional relevant MeSH terms:
Brain Death
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Coma
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Death
Pathologic Processes