Transcranial Doppler Ultrasonography and Brain Death
Evaluation of Transcranial Doppler Ultrasonography to Guide the Time of Cerebral Angiography for the Brain Death Diagnosis
1 other identifier
observational
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2009
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 12, 2010
CompletedFirst Posted
Study publicly available on registry
February 18, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedJuly 4, 2011
June 1, 2011
2.3 years
February 12, 2010
June 30, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time between clinical diagnosis of brain death and realization of CT angiography
the outcome is assessed when the CT angiography is performed
Secondary Outcomes (1)
Number of CT angiography required for the diagnosis of brain death
the outcome is measured until the diagnosis of brain death is confirmed
Study Arms (2)
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.
Interventions
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 Criteria
ICU patients showing brain injury due to stroke or trauma and developping subsequently brain death
You may qualify if:
- brain death patients
You may not qualify if:
- craniectomy
- post anoxia encephalopathy
- no TCD performed before the clinical diagnosis of brain death
- transtemporal approach impossible
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier Universitaire de Nice
Nice, 06000, France
Related Publications (1)
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. doi: 10.1097/TP.0b013e3182612947.
PMID: 22918218DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Christophe Orban, MD
Nice University Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 12, 2010
First Posted
February 18, 2010
Study Start
February 1, 2009
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
July 4, 2011
Record last verified: 2011-06