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OpenTrials
Completed

NCT Number: NCT01024452

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DAWN AC

Device

computerized dosing management system for anticoagulation clinics

Other names: DAWN AC, 4S Information Systems Ltd.

Hamilton Nomogram

Device

simple nomogram for warfarin maintenance dosing

Other names: Nomogram (algorithm)

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Population Health Research Institute

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 2, 2009
Registry last updated
Jul 20, 2011

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.