Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000701022
Ethics application status
Approved
Date submitted
20/08/2010
Date registered
24/08/2010
Date last updated
7/07/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Study to Determine the Accuracy of Prothrombin Time of Warfarinised blood.
Scientific title
In patients taking warfarin, how do the Prothrombin(PT)/International Normalised Ratio (INR) results from Universal Biosensors, CoaguChek point-of-care INR devices correlate to a standard laboratory laboratory method.
Secondary ID [1] 252516 0
Nil
Universal Trial Number (UTN)
N/A
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
A prothrombin time test (PT) used to monitor patients taking the anticoagulant warfarin 258005 0
Condition category
Condition code
Blood 258174 258174 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this study is to measure prothrombin time (PT) expressed in International Normalised Ratio (INR) units in persons receiving warfarin treatment on an experimental device, commercially available point of care device and a standard laboratory method.
This will involve taking a venous sample from both persons receiving warfarin treatment (experimental group) and persons not receiving warfarin treatment (control group). All persons are currently undergoing testing at a clinic. Samples collected are tested by laboratory staff on the experimental point of care device, commercially available device and standard laboratory reference instrument.
It is expected that the persons participation does not exceed the time it takes to complete informed consent form and have a venous sample collected.
Intervention code [1] 257056 0
Other interventions
Comparator / control treatment
No treatments are administered as part of this study. Control group are subjects not receiving warfarin treatment.
Control group
Active

Outcomes
Primary outcome [1] 259040 0
International Normalised Ratio(INR) values from the Universal Biosensors device will correlate with results obtained from the Roche CoaguChek and the laboratory reference method.
Timepoint [1] 259040 0
Results will be displayed immediately
Secondary outcome [1] 265291 0
International Normalised Ratio(INR) values from the Universal Biosensors device will correlate with results obtained from the Roche CoaguChek and the laboratory reference method over the extended range of haematocrits.
Timepoint [1] 265291 0
Results will be displayed immediately.

Eligibility
Key inclusion criteria
Patients currently receiving warfarin treatment
Patients not receiving warfarin treatment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257502 0
Commercial sector/Industry
Name [1] 257502 0
Universal Biosensors Pty Ltd
Country [1] 257502 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Universal Biosensors Pty Ltd
Address
1 Corporate Ave.
Rowville, VIC
Country
Australia
Secondary sponsor category [1] 256735 0
None
Name [1] 256735 0
Address [1] 256735 0
Country [1] 256735 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259530 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 259530 0
55 Commercial Road
Melbourne 3004
Ethics committee country [1] 259530 0
Australia
Date submitted for ethics approval [1] 259530 0
23/08/2010
Approval date [1] 259530 0
13/01/2011
Ethics approval number [1] 259530 0

Summary
Brief summary
This study will involve taking a venous sample from both persons receiving warfarin treatment (experimental group) and persons not receiving warfarin treatment (control group). All persons are currently undergoing testing at a clinic. Samples collected are tested by laboratory staff on the experimental point of care device, commercially available device and standard laboratory reference instrument.
The aim of this study is to measure prothrombin time (PT) expressed in International Normalised Ratio (INR) units in persons receiving warfarin treatment on an experimental device, commercially available point of care device and a standard laboratory method.
It is expected that International Normalised Ratio(INR) values from the Universal Biosensors device will correlate with results obtained from the Roche CoaguChek and the laboratory reference method.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31547 0
Address 31547 0
Country 31547 0
Phone 31547 0
Fax 31547 0
Email 31547 0
Contact person for public queries
Name 14794 0
Kristyn Forsayeth
Address 14794 0
1 Corporate Ave.
Rowville VIC, 3178
Country 14794 0
Australia
Phone 14794 0
+61 3 9213 9000
Fax 14794 0
+61 3 9213 9099
Email 14794 0
kforsayeth@universalbiosensors.com
Contact person for scientific queries
Name 5722 0
Peter Newman
Address 5722 0
1 Corporate Ave.
Rowville VIC, 3178
Country 5722 0
Australia
Phone 5722 0
+ 61 3 9213 9003
Fax 5722 0
+ 61 3 9213 9099
Email 5722 0
pnewman@universalbiosensors.com

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.