Trial Review

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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
Sir Charles Gairdner Hospital Hospital Avenue Nedlands Wesrern Australia 6009
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
Point of Care (POC)technology as the potential to expediate decision making and therefore benedit patient care and flow throught the Emergency Department. POC International Normalised Ratio (INR) is in common use in the community for monitoring warfarin therapy use. If found to be accurate as a marker of coagulopathy for emergency patients would potentially be a useful addition to tests available to the Emergency Physician
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.