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

Primary Purpose

Patients at Risk for Thrombosis

Status

Completed

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

DAWN AC

Hamilton Nomogram

About this trial

This is an interventional treatment trial for Patients at Risk for Thrombosis focused on measuring anticoagulation, warfarin, computer systems, international normalized ratio, nomograms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hamilton General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DAWN AC

Hamilton Nomogram

Arm Description

Outcomes

Primary Outcome Measures

TTR: The proportion of time a patient spends in the therapeutic INR range (2-3)

Secondary Outcome Measures

Full Information

NCT ID

NCT01024452

First Posted

December 1, 2009

Last Updated

July 19, 2011

Sponsor

Population Health Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT01024452

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2009

Overall Recruitment Status

Completed

Study Start Date

November 2009 (undefined)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Population Health Research Institute

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Patients at Risk for Thrombosis

Keywords

anticoagulation, warfarin, computer systems, international normalized ratio, nomograms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

1298 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DAWN AC

Arm Type

Experimental

Arm Title

Hamilton Nomogram

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

DAWN AC

Other Intervention Name(s)

DAWN AC, 4S Information Systems Ltd.

Intervention Description

computerized dosing management system for anticoagulation clinics

Intervention Type

Device

Intervention Name(s)

Hamilton Nomogram

Other Intervention Name(s)

Nomogram (algorithm)

Intervention Description

simple nomogram for warfarin maintenance dosing

Primary Outcome Measure Information:

Title

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stuart Connolly, MD

Organizational Affiliation

Director, Division of Cardiology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hamilton General Hospital

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8L 2X2

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

19277410

Citation

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. Erratum In: Thromb Haemost. 2009 Apr;101(4):794.

Results Reference

background

PubMed Identifier

19840361

Citation

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.

Results Reference

background

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

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