Status:
TERMINATED
Randomized Controlled Feasibility Trial of the Fearon Algorithm to Improve Management of Unstable Warfarin
Lead Sponsor:
McMaster University
Collaborating Sponsors:
Epitome Pharmaceuticals
Conditions:
Hypoprothrombinemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Patients on warfarin but with unstable international normalized ratio (INR) will be recruited to a randomized trial comparing dosing based on an algorithm (Fearon algorithm, named after the mathematic...
Detailed Description
Patients with very variable INRs resulting in a low proportion of time in therapeutic range (TTR) have a higher risk of both bleeding complications and thromboembolic events. A good TTR is generally c...
Eligibility Criteria
Inclusion
- Patients with mechanical heart valve prosthesis managed for the warfarin therapy by the Thrombosis Service at HHS-General Hospital.
- Treated with warfarin for at least 1 year.
- Therapeutic INR range 2.0-3.0 or 2.5-3.5.
- TTR in the lowest quartile
Exclusion
- Known poor compliance due to for example alcohol abuse or cognitive impairment
- Refusal to provide written informed consent
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 3 2017
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT02267408
Start Date
November 1 2014
End Date
February 3 2017
Last Update
April 6 2018
Active Locations (1)
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1
Thrombosis Service, HHS-General Hospital
Hamilton, Ontario, Canada, L8L 2X2