Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12608000034336
Ethics application status
Approved
Date submitted
20/01/2008
Date registered
21/01/2008
Date last updated
9/11/2018
Date data sharing statement initially provided
9/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Transient amnesia assessment and management in an emergency department
Scientific title
Do patients with acute memory disturbance following straining have a higher proportion of jugular venous backflow than those that present without straining?
Universal Trial Number (UTN)
Trial acronym
TAMED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Transient Amnesia 2730 0
Condition category
Condition code
Neurological 2857 2857 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Ultrasound scan of bilateral internal jugular veins - once only scan lasting for approx 10 minutes.
Intervention code [1] 2472 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3739 0
Proportion of participants with internal jugular reflux during Valsalva manouvre
Timepoint [1] 3739 0
Feb 2008 to Feb 2010
Secondary outcome [1] 6314 0
Proportion of participants with recurrence, acute neurological event, cardiovascular event, death
Timepoint [1] 6314 0
Feb 2010

Eligibility
Key inclusion criteria
Patients with acute memory disturbance presenting to an emergency department
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Case control
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
15/02/2008
Actual
15/02/2008
Date of last participant enrolment
Anticipated
Actual
15/02/2010
Date of last data collection
Anticipated
Actual
15/02/2010
Sample size
Target
80
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 736 0
6009

Funding & Sponsors
Funding source category [1] 2987 0
University
Name [1] 2987 0
University of Western Australia
Country [1] 2987 0
Australia
Funding source category [2] 2994 0
University
Name [2] 2994 0
university of Western Australia
Country [2] 2994 0
Australia
Primary sponsor type
Other
Name
University of Western Australia
Address
Stirling Highway
Crawley 6009
Country
Australia
Secondary sponsor category [1] 2697 0
None
Name [1] 2697 0
Address [1] 2697 0
Country [1] 2697 0
Secondary sponsor category [2] 2701 0
None
Name [2] 2701 0
Address [2] 2701 0
Country [2] 2701 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4946 0
Sir Charles Gairdner Hospital HREC
Ethics committee address [1] 4946 0
Hospital Avenue
Nedlands WA 6009
Ethics committee country [1] 4946 0
Australia
Date submitted for ethics approval [1] 4946 0
28/01/2008
Approval date [1] 4946 0
15/02/2008
Ethics approval number [1] 4946 0

Summary
Brief summary
Aims of the study:
1. To determine the eventual diagnoses of patients presenting to emergency departments with acute amnesia.
2. To determine the ED assessment and management of transient global amnesia and correlate with current diagnostic criteria and suggested management.
3. To compare proportions of patients with internal jugular vein backflow among those that present with TGA, either precipitated by an episode of straining, or not.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28309 0
Address 28309 0
Country 28309 0
Phone 28309 0
Fax 28309 0
Email 28309 0
Contact person for public queries
Name 11466 0
Antonio Celenza
Address 11466 0
Level 2, R Block
QE II Medical Centre
Nedlands 6009
Country 11466 0
Australia
Phone 11466 0
93463333
Fax 11466 0
Email 11466 0
[email protected]
Contact person for scientific queries
Name 2394 0
Antonio Celenza
Address 2394 0
Level 2, R Block
QE II Medical Centre
Nedlands 6009
Country 2394 0
Australia
Phone 2394 0
93463333
Fax 2394 0
Email 2394 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.