Transcranial doppler sonography with a transorbital approach as a confirmatory test in the diagnosis of brain death

ISRCTN ISRCTN49093383
DOI https://doi.org/10.1186/ISRCTN49093383
Protocol serial number N/A
Sponsor Athens General Hospital "G. Gennimatas" (Greece)
Funder Athens General Hospital "G. Gennimatas" (Greece) - Intensive Care Unit (ICU) Department
Submission date
26/09/2008
Registration date
27/10/2008
Last edited
27/10/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Andreas Karabinis
Scientific

154 Mesogeion Ave
Athens
11527
Greece

Phone +30 21 0748 0188
Email echolabicu@gmail.com

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study objectivesThis study was designed to evaluate whether the routine addition of the transorbital doppler examination of the carotid siphon in patients suspected of brain death improves the efficiency of the transcranial doppler examination protocol.
Ethics approval(s)The study was approved by the Institutional Ethics Committee of the General State Hospital of Athens in 2005 (ref: ICUTCD2005/2).
Health condition(s) or problem(s) studiedBrain death
InterventionAll patients underwent cerebral angiography, transcranial doppler examination of the basilar, anterior and middle cerebral arteries bilaterally. In addition, the patients in the intervention group were assessed by transorbital doppler of the carotid siphons bilaterally.
Intervention typeOther
Primary outcome measure(s)

Blood flow patterns measured by transcranial doppler sonography with a suboccipital, transtemporal and transorbital approach.

Key secondary outcome measure(s)

Efficacy of the transorbital approach in the diagnosis of brain death with transcranial doppler sonography.

Completion date31/07/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Target sample size at registration79
Key inclusion criteriaBrain dead patients of the intensive care unit (both males and females, aged greater than 16 years) who were hospitalised from October 2005 to July 2008.
Key exclusion criteria1. Patients with an episode of hypoxia or hypotension during the angiographic or transcranial doppler examinations
2. Patients with no flow at the initial transcranial doppler examination in any approach
Date of first enrolment01/10/2005
Date of final enrolment31/07/2008

Locations

Countries of recruitment

  • Greece

Study participating centre

154 Mesogeion Ave
Athens
11527
Greece

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan