Trial Review

Please note that the ANZCTR website will be unavailable from 1:00pm until 2:00pm (AEST) on Thursday 10th of April for website maintenance. Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.


The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

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
ACTRN12609000383268
Ethics application status
Approved
Date submitted
3/04/2009
Date registered
29/05/2009
Date last updated
29/05/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of Point of care International Normalised Ratio(INR)and laboratory INR in patients presenting to an Emergency Department to determine accuracy and clinical utility
Scientific title
Comparison of Point of Care International Normalised Ratios (INR) to laboratory INRs in patients presenting to an Emergency Department to determine accuracy and clinical utility
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
coagulation 4562 0
Condition category
Condition code
Blood 4854 4854 0 0
Clotting disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
patients requiring international normalised ratio (INR) as part of their assessment have venepuncture performed and less than one ml of the venepeuncture drawn blood is simultaneously used for the point of care (POC) INR test and a comparison of the results is then carried out
Intervention code [1] 4325 0
Not applicable
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5709 0
90% agreement between the Point of Care (POC) and laboratory International Normalised ratio (INR) where agreement is defined as the POC result within 15% of the laboratory result
Timepoint [1] 5709 0
both investigations use the same blood drawn via venepuncture. The laboratory result when available is then compared to the result from the point of care machine which is done as soon as possible after venepuncture
Secondary outcome [1] 241868 0
assessment of clinical utility
Timepoint [1] 241868 0
emergency department management

Eligibility
Key inclusion criteria
INR being tested
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
INR not tested

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/04/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
312
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4750 0
Hospital
Name [1] 4750 0
Sir Charles Gairdner Hospital Emergency Department
Country [1] 4750 0
Australia
Funding source category [2] 4875 0
Hospital
Name [2] 4875 0
Sir Charles Gairdner Hospital Emergency Department
Country [2] 4875 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital Emergency Department
Address
Hospital Avenue Nedlands Perth WA 6009
Country
Australia
Secondary sponsor category [1] 4290 0
None
Name [1] 4290 0
Address [1] 4290 0
Country [1] 4290 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6793 0
Human Research Ethics Commitee
Ethics committee address [1] 6793 0
Ethics committee country [1] 6793 0
Australia
Date submitted for ethics approval [1] 6793 0
Approval date [1] 6793 0
Ethics approval number [1] 6793 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29462 0
Address 29462 0
Country 29462 0
Phone 29462 0
Fax 29462 0
Email 29462 0
Contact person for public queries
Name 12709 0
Antonio Celenza
Address 12709 0
Emergency Medicine R Block Sir Charles Gairdner Hospital Hospital Avenue Nedlands WA 6009
Country 12709 0
Australia
Phone 12709 0
+618 9346 4355
Fax 12709 0
Email 12709 0
tony.celenza@uwa,edu.au
Contact person for scientific queries
Name 3637 0
Antonio Celenza
Address 3637 0
Emergency Medicine R Block Sir Charles Gairdner Hospital Hospital Avenue Nedlands WA 6009
Country 3637 0
Australia
Phone 3637 0
+618 9346 4355
Fax 3637 0
Email 3637 0
[email protected]

No information has been provided regarding IPD availability


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.