Hamilton General Hospital
Hamilton, Ontario, L8L 2X2, Canada
NCT Number: NCT01024452
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 3
Hamilton, Ontario, L8L 2X2, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
computerized dosing management system for anticoagulation clinics
Other names: DAWN AC, 4S Information Systems Ltd.
simple nomogram for warfarin maintenance dosing
Other names: Nomogram (algorithm)
Time frame: TTR calculated over the entire study period (6 months)
Population Health Research Institute
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.