Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001304729
Ethics application status
Approved
Date submitted
19/11/2013
Date registered
22/11/2013
Date last updated
13/10/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
A multicentre, observational, prospective study of the current practice in major centres in Australia and New Zealand for achieving haemostasis in consecutive patients who present with significant haemorrhage, thromboembolism or urgent surgery whilst on new or established oral anticoagulants
Scientific title
A multicentre, observational, prospective study of the current practice in major centres in Australia and New Zealand for achieving haemostasis in consecutive patients who present with significant haemorrhage, thromboembolism or urgent surgery whilst on new or established oral anticoagulants
Secondary ID [1] 283620 0
Nil
Universal Trial Number (UTN)
U1111-1150-5237
Trial acronym
ARES Collaborative
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Significant haemorrhage 290545 0
Thromboembolism 290546 0
Urgent surgery 290547 0
Condition category
Condition code
Blood 290946 290946 0 0
Other blood disorders

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
30
Target follow-up type
Days
Description of intervention(s) / exposure
This is an observational study to document in major centres in Australia and New Zealand the current practice for achieving haemostasis in patients who present with significant haemorrhage, thromboembolism or require anticoagulant reversal for urgent surgery and/or a procedure whilst on new (dabigatran, rivaroxaban, or apixaban) or established (warfarin) oral anticoagulants. The duration of the study is 42 months.
Intervention code [1] 288314 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290926 0
To observe the current practice for achieving haemostasis in 2000 patients who present with significant haemorrhage or urgent surgery whilst on new (dabigatran, rivaroxaban, apixaban or endoxaban) or established (warfarin) oral anticoagulants. Data will be collected by reviewing patients’ medical records.
Timepoint [1] 290926 0
42 months
Secondary outcome [1] 305614 0
In patients whilst on oral anticoagulants who present with embolism, determine the circumstances and level of anticoagulation at the time of presentation. Data will be collected by reviewing patients’ medical records.
Timepoint [1] 305614 0
42 months

Eligibility
Key inclusion criteria
Patients presenting with significant haemorrhage, thromboembolism or require anticoagulation reversal for urgent surgery and/or a procedure and have taken a NOAC (dabigatran, rivaroxaban, or apixaban) or warfarin within the last 7 days.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have minor haemorrhage responding to local measures not requiring admission, blood testing or change in anticoagulant management.

Patients who are unable to have objective testing for recurrence of thromboembolism.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Both
Statistical methods / analysis
Around 240,000 Australian patients are currently on OAC of which around 13% are on a new oral anticoagulant (NOAC). Major bleeding occurs in 2-3% of patients on OAC and embolism in 1-2% per year. 2000 patients will be recruited to obtain a cross-sectional sample to document the standard of care for these patients.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/05/2012
Actual
20/05/2012
Date of last participant enrolment
Anticipated
30/09/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Recruitment outside Australia
Country [1] 5644 0
New Zealand
State/province [1] 5644 0

Funding & Sponsors
Funding source category [1] 288300 0
Other Collaborative groups
Name [1] 288300 0
Australasian Society of Thrombosis and Haemostasis (ASTH)
Country [1] 288300 0
Australia
Primary sponsor type
Other Collaborative groups
Name
ARES Collaborative
Address
c/o The Perth Blood Institute
Hollywood Specialist Centre
Suite 3/95 Monash Avenue
Nedlands
WA 6009
Australia
Country
Australia
Secondary sponsor category [1] 287020 0
Other Collaborative groups
Name [1] 287020 0
ASTH
Address [1] 287020 0
PO Box 217
Glen Iris
Victoria 3146
Australia
Country [1] 287020 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290197 0
Royal Perth Hospital HREC
Ethics committee address [1] 290197 0
Ethics committee country [1] 290197 0
Australia
Date submitted for ethics approval [1] 290197 0
Approval date [1] 290197 0
01/05/2012
Ethics approval number [1] 290197 0
2012/071
Ethics committee name [2] 291797 0
Sydney Local Health District HREC
Ethics committee address [2] 291797 0
Ethics committee country [2] 291797 0
Australia
Date submitted for ethics approval [2] 291797 0
28/06/2012
Approval date [2] 291797 0
30/08/2012
Ethics approval number [2] 291797 0
HREC/12/CRGH/102

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

Contacts
Principal investigator
Name 44434 0
Prof Ross Baker
Address 44434 0
The Perth Blood Institute
Hollywood Medical Centre
Suite 37/85 Monash Avenue
Nedlands
WA 6009
Country 44434 0
Australia
Phone 44434 0
+61 892002236
Fax 44434 0
Email 44434 0
info@aptin.org
Contact person for public queries
Name 44435 0
Wendy Angelatos
Address 44435 0
The Perth Blood Institute Hollywood Specialist Centre, Suite 3/95 Monash Avenue Nedlands WA 6009
Country 44435 0
Australia
Phone 44435 0
+61 892004904
Fax 44435 0
Email 44435 0
info@aptin.org
Contact person for scientific queries
Name 44436 0
Ross Baker
Address 44436 0
The Perth Blood Institute
Hollywood Medical Centre
Suite 37/85 Monash Avenue
Nedlands
WA 6009
Country 44436 0
Australia
Phone 44436 0
+61 892002236
Fax 44436 0
Email 44436 0
info@aptin.org

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.