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Randomized Comparison of Warfarin Dosing Quality Between the Hamilton Nomogram and a Commercial Computer System

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ClinicalTrials.gov Identifier: NCT01024452
Recruitment Status : Completed
First Posted : December 2, 2009
Last Update Posted : July 20, 2011
Sponsor:
Information provided by:
Population Health Research Institute

December 1, 2009
December 2, 2009
July 20, 2011
November 2009
August 2010   (Final data collection date for primary outcome measure)
TTR: The proportion of time a patient spends in the therapeutic INR range (2-3) [ Time Frame: TTR calculated over the entire study period (6 months) ]
TTR: The time in therapeutic INR range (2-3) of patients followed by the anticoagulation clinic [ Time Frame: TTR calculated at end of study ]
Complete list of historical versions of study NCT01024452 on ClinicalTrials.gov Archive Site
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Randomized Comparison of Warfarin Dosing Quality Between the Hamilton Nomogram and a Commercial Computer System
Randomized Comparison of Warfarin Dosing Quality Between the Hamilton Nomogram and a Commercial Computer System

Randomized comparison of warfarin dosing quality between the Hamilton nomogram and a commercial computer system.

Hypothesis: Mean TTR of patients managed with the commercial computer system is non-inferior to management with the validated Hamilton Nomogram.

Warfarin has a variable effect and many potential food and drug interactions. To have an optimal therapeutic effect the International Normalized Ratio (INR) needs to be maintained within the therapeutic target range. The time that a patient spends within the therapeutic target range is an intermediate quality indicator for patient outcomes and should be optimized. For this purpose, we use in our anticoagulation clinic the simple two-step Hamilton nomogram, which has been validated by Kim et al. who showed that the nomogram improved INR control for warfarin maintenance compared with expertise-based dosing in our anticoagulation clinic (see references). Computer systems are also known to outperform expertise-based dosing, but no direct comparison of a computer system with a simple nomogram has been assessed. In this single-center randomized controlled clinical trial we will compare the simple two-step Hamilton nomogram with the widely used computerized dosing management system DAWN AC regarding their effect on time in therapeutic range for patients on maintenance dosing with target range 2-3.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Patients at Risk for Thrombosis
  • Device: DAWN AC
    computerized dosing management system for anticoagulation clinics
    Other Name: DAWN AC, 4S Information Systems Ltd.
  • Device: Hamilton Nomogram
    simple nomogram for warfarin maintenance dosing
    Other Name: Nomogram (algorithm)
  • Experimental: DAWN AC
    Intervention: Device: DAWN AC
  • Active Comparator: Hamilton Nomogram
    Intervention: Device: Hamilton Nomogram

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1298
1500
August 2010
August 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • On warfarin maintenance therapy
  • INR target range 2-3
  • At least 3 historical INRs on maintenance therapy
  • At least 1 historical INR in the last 3 months

Exclusion Criteria:

  • Participation in another study
  • On multiple pill strengths
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01024452
09-283
No
Not Provided
Not Provided
Dr. S. Connolly, Population Health Research Institute
Population Health Research Institute
Not Provided
Principal Investigator: Stuart Connolly, MD Director, Division of Cardiology
Population Health Research Institute
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP