Condition category
Nervous System Diseases
Date applied
26/09/2008
Date assigned
27/10/2008
Last edited
27/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Andreas Karabinis

ORCID ID

Contact details

154 Mesogeion Ave
Athens
11527
Greece
+30 21 0748 0188
echolabicu@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

This 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

The study was approved by the Institutional Ethics Committee of the General State Hospital of Athens in 2005 (ref: ICUTCD2005/2).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

Brain death

Intervention

All 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 type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

01/10/2005

Overall trial end date

31/07/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Brain 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

79

Participant exclusion criteria

1. 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

Recruitment start date

01/10/2005

Recruitment end date

31/07/2008

Locations

Countries of recruitment

Greece

Trial participating centre

154 Mesogeion Ave
Athens
11527
Greece

Sponsor information

Organisation

Athens General Hospital "G. Gennimatas" (Greece)

Sponsor details

ICU Department
154 Mesogeion Ave
Athens
11527
Greece
theosol@hotmail.com

Sponsor type

Hospital/treatment centre

Website

http://www.gna-gennimatas.gr

Funders

Funder type

Hospital/treatment centre

Funder name

Athens General Hospital "G. Gennimatas" (Greece) - Intensive Care Unit (ICU) Department

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes