Trial Review

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Please note the ANZCTR will be unattended on Monday the 27th of January due to the national public holiday.

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
ACTRN12625000075482p
Ethics application status
Not yet submitted
Date submitted
29/01/2025
Date registered
29/01/2025
Date last updated
29/01/2025
Date data sharing statement initially provided
29/01/2025
Date results provided
29/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
testing adding docs after sub 29012025
Scientific title
testing adding docs after sub 29012025
Secondary ID [1] 313803 0
testing adding docs after sub 29012025
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
testing adding docs after sub 29012025 336439 0
Condition category
Condition code
Blood 332960 332960 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
testing adding docs after sub 29012025
testing adding docs after sub 29012025
testing adding docs after sub 29012025
testing adding docs after sub 29012025
testing adding docs after sub 29012025
testing adding docs after sub 29012025
Intervention code [1] 330392 0
Early detection / Screening
Comparator / control treatment
testing adding docs after sub 29012025
testing adding docs after sub 29012025
testing adding docs after sub 29012025
testing adding docs after sub 29012025
testing adding docs after sub 29012025
Control group
Active

Outcomes
Primary outcome [1] 340498 0
testing adding docs after sub 29012025
Timepoint [1] 340498 0
testing adding docs after sub 29012025
Secondary outcome [1] 444270 0
testing adding docs after sub 29012025
Timepoint [1] 444270 0
testing adding docs after sub 29012025

Eligibility
Key inclusion criteria
testing adding docs after sub 29012025
testing adding docs after sub 29012025
testing adding docs after sub 29012025
testing adding docs after sub 29012025
testing adding docs after sub 29012025
testing adding docs after sub 29012025
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
testing adding docs after sub 29012025
testing adding docs after sub 29012025
testing adding docs after sub 29012025
testing adding docs after sub 29012025
testing adding docs after sub 29012025

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
testing adding docs after sub 29012025
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
testing adding docs after sub 29012025
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/02/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 318270 0
University
Name [1] 318270 0
testing adding docs after sub 29012025
Country [1] 318270 0
Australia
Primary sponsor type
University
Name
testing adding docs after sub 29012025
Address
Country
Australia
Secondary sponsor category [1] 320658 0
None
Name [1] 320658 0
Address [1] 320658 0
Country [1] 320658 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 316910 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 316910 0
Ethics committee country [1] 316910 0
Australia
Date submitted for ethics approval [1] 316910 0
31/01/2025
Approval date [1] 316910 0
Ethics approval number [1] 316910 0

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

Contacts
Principal investigator
Name 139406 0
Dr testing adding docs after sub 29012025
Address 139406 0
testing adding docs after sub 29012025
Country 139406 0
Australia
Phone 139406 0
+61 2 9562 5333
Fax 139406 0
Email 139406 0
[email protected]
Contact person for public queries
Name 139407 0
testing adding docs after sub 29012025
Address 139407 0
testing adding docs after sub 29012025
Country 139407 0
Australia
Phone 139407 0
+61 2 9562 5333
Fax 139407 0
Email 139407 0
[email protected]
Contact person for scientific queries
Name 139408 0
testing adding docs after sub 29012025
Address 139408 0
testing adding docs after sub 29012025
Country 139408 0
Australia
Phone 139408 0
+61 2 9562 5333
Fax 139408 0
Email 139408 0
[email protected]

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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24481Data dictionary    attached before submission 389087-(Uploaded-29-01-2025-11-24-51)-ANZCTR Data field explanation_Jan2024.pdf



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.