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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAWN AC | Experimental |
| |
| Hamilton Nomogram | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DAWN AC | Device | computerized dosing management system for anticoagulation clinics |
|
| Measure | Description | Time Frame |
|---|---|---|
| TTR: The proportion of time a patient spends in the therapeutic INR range (2-3) | TTR calculated over the entire study period (6 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stuart Connolly, MD | Director, Division of Cardiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton General Hospital | Hamilton | Ontario | L8L 2X2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19277410 | Background | Poller L, Keown M, Ibrahim S, Lowe G, Moia M, Turpie AG, Roberts C, van den Besselaar AM, van der Meer FJ, Tripodi A, Palareti G, Shiach C, Bryan S, Samama M, Burgess-Wilson M, Heagerty A, Maccallum P, Wright D, Jespersen J; European Action on Anticoagulation (EAA). A multicentre randomised assessment of the DAWN AC computer-assisted oral anticoagulant dosage program. Thromb Haemost. 2009 Mar;101(3):487-94. | |
| 19840361 |
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| ID | Term |
|---|---|
| D049451 | Nomograms |
| ID | Term |
|---|---|
| D011379 | Prognosis |
| D003933 | Diagnosis |
| D015233 | Models, Statistical |
| D013223 | Statistics as Topic |
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| Hamilton Nomogram | Device | simple nomogram for warfarin maintenance dosing |
|
|
| Background |
| Kim YK, Nieuwlaat R, Connolly SJ, Schulman S, Meijer K, Raju N, Kaatz S, Eikelboom JW. Effect of a simple two-step warfarin dosing algorithm on anticoagulant control as measured by time in therapeutic range: a pilot study. J Thromb Haemost. 2010 Jan;8(1):101-6. doi: 10.1111/j.1538-7836.2009.03652.x. Epub 2009 Oct 14. |
| D004812 |
| Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D008962 | Models, Theoretical |
| D055641 | Mathematical Concepts |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |