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Transcranial Doppler Ultrasonography and Brain Death

This study has been completed.
Sponsor:
Information provided by:
Institut d'Anesthesiologie des Alpes Maritimes
ClinicalTrials.gov Identifier:
NCT01070563
First received: February 12, 2010
Last updated: June 30, 2011
Last verified: June 2011
History of Changes
  Purpose

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 Intervention
Brain Dead
 Other: Transcranial doppler

Study Type: Observational
Study Design: 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

Further study details as provided by Institut d'Anesthesiologie des Alpes Maritimes:

Primary Outcome Measures:
  • Time between clinical diagnosis of brain death and realization of CT angiography [ Time Frame: the outcome is assessed when the CT angiography is performed ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 44
Study Start Date: February 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Institut d'Anesthesiologie des Alpes Maritimes

Additional 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
Study First Received: February 12, 2010
Last Updated: June 30, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on May 22, 2013