Transcranial Doppler Ultrasonography and Brain Death

Brain Dead Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01070563
• Other study ID #: IAAM 2010-1
• Status: Completed
• Phase: N/A
• First received: February 12, 2010
• Last updated: June 30, 2011
• Start date: February 2009
• Est. completion date: June 2011

Study information

• Verified date: June 2011
• Source: Institut d'Anesthesiologie des Alpes Maritimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Dead
• Brain Death

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Institut d'Anesthesiologie des Alpes Maritimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time between clinical diagnosis of brain death and realization of CT angiography		the outcome is assessed when the CT angiography is performed	No
Secondary	Number of CT angiography required for the diagnosis of brain death		the outcome is measured until the diagnosis of brain death is confirmed	No