NCT01070563

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 12, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 18, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

July 4, 2011

Status Verified

June 1, 2011

Enrollment Period

2.3 years

First QC Date

February 12, 2010

Last Update Submit

June 30, 2011

Conditions

Keywords

Brain deathCT angiographyUltrasonography, doppler, transcranial

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.

Other: Transcranial doppler

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

TCD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Location

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.

MeSH Terms

Conditions

Brain Death

Interventions

Ultrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesComaUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EchoencephalographyNeuroradiographyNeuroimagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographyUltrasonographyUltrasonography, DopplerDiagnostic Techniques, NeurologicalInvestigative Techniques

Study Officials

  • Jean-Christophe Orban, MD

    Nice University Hospital

    PRINCIPAL INVESTIGATOR

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

Locations