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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01795781




Registration number
NCT01795781
Ethics application status
Date submitted
14/02/2013
Date registered
21/02/2013
Date last updated
3/05/2013

Titles & IDs
Public title
Assays for and Reversal of New Anticoagulants
Scientific title
Development of Anticoagulant Assays for New Anticoagulants and Their Reversibility in Vitro
Secondary ID [1] 0 0
2011/117
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Osteoarthritis of the Knee 0 0
Osteoarthritis of the Hip 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients receiving a new anticoagulant - Patients are receiving dabigatran for atrial fibrillation or rivaroxaban for osteoarthritis of hip or knee undergoing total hip or knee replacement respectively
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Ability to reverse anticoagulant effect in vitro of dabigatran or rivarovaban
Timepoint [1] 0 0
Two hours after ingestion of anticoagulant dose

Eligibility
Key inclusion criteria
- Receiving dabigatran for atrial fibrillation

- Or,for osteoarthritis of the hip or knee receiving rivaroxaban to prevent
thromboembolic disease after total hip or knee replacement respectively
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Failure to sign informed consent

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2013
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
6000 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
R.P.Herrmann
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
New anticoagulants are being introduced to replace warfarin. These drugs do not require
monitoring and are safer. There is currently no recommended way to reverse these drugs
rapidly in the event of undue bleeding or need for emergency surgery. This is a lab study to
look at ways to reverse the drugs rapidly
Trial website
https://clinicaltrials.gov/ct2/show/NCT01795781
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ross I Baker, MB, BS
Address 0 0
Royal Perth Hospital, Wellington St, Perth, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries