Transcranial Doppler Ultrasonography and Brain Death

Sponsor

Institut d'Anesthesiologie des Alpes Maritimes (Other)

Overall Status

Completed

CT.gov ID

NCT01070563

Collaborator

(none)

Enrollment

Location

27.9

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Brain Dead	Other: Transcranial doppler

Study Design

Study Type:

Observational

Anticipated 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 :

Feb 1, 2009

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Jun 1, 2011

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Time between clinical diagnosis of brain death and realization of CT angiography [the outcome is assessed when the CT angiography is performed]

Secondary Outcome Measures

Number of CT angiography required for the diagnosis of brain death [the outcome is measured until the diagnosis of brain death is confirmed]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01070563

Other Study ID Numbers:

IAAM 2010-1

First Posted:

Feb 18, 2010

Last Update Posted:

Jul 4, 2011

Last Verified:

Jun 1, 2011

Keywords provided by , ,

Brain death

CT angiography

Ultrasonography, doppler, transcranial

Additional relevant MeSH terms:

Brain Death

Study Results

No Results Posted as of Jul 4, 2011