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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

February 12, 2010
June 30, 2011
February 2009
June 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01070563 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Transcranial Doppler Ultrasonography and Brain Death
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.
Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

ICU patients showing brain injury due to stroke or trauma and developping subsequently brain death
Brain Dead
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
  • 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.
    Intervention: Other: Transcranial doppler
Orban JC, El-Mahjoub A, Rami L, Jambou P, Ichai C. Transcranial Doppler shortens the time between clinical brain death and angiographic confirmation: a randomized trial. Transplantation. 2012 Sep 27;94(6):585-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
June 2011
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • brain death patients

Exclusion Criteria:

  • craniectomy
  • post anoxia encephalopathy
  • no TCD performed before the clinical diagnosis of brain death
  • transtemporal approach impossible
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01070563
IAAM 2010-1
No
Orban Jean-Christophe, MD, Nice University Hospital
Institut d'Anesthesiologie des Alpes Maritimes
Not Provided
Principal Investigator: Jean-Christophe Orban, MD Nice University Hospital
Institut d'Anesthesiologie des Alpes Maritimes
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP