Prospective Trial of a Validated Algorithm for Warfarin Dosing

The aim of this study is to perform a randomized trial comparing the use of the algorithm, with dosing of warfarin in standard manual dosage clinical practice, in a high quality anticoagulant setting (PSM). This is done for safety concerns and to ensure good performance of the algorithm when used in a clinical setup. The results from the study are expected to increase our knowledge of efficacy by using the algorithm in clinical practice.

Study Overview

• Status: Completed
• Conditions: Anticoagulation
• Intervention / Treatment: Other: Active Comparator; Other: Experimental

• Study Type: Interventional
• Enrollment (Actual): 211
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

• Participants will be those ≥18 years old, must refer to Trombosecenter Aalborg and have to be educated as PSM patient
• Have to be treated for at least 1 month and willing to sign informed consent

Exclusion Criteria

• OAT treatment with phenprocoumon
• Lack of ability to handle the interface on the software used in the study (evaluated by the investigator present at the information meeting)
• Pregnancy
• Those with severe co-morbidities (e.g., creatinine > 2.5, hepatic insufficiency, active malignancy, advanced physiological age, noncompliance risk, expected survival <6 months), and physician or patient preference.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: self-managing warfarin; self-managing warfarin patients who are educated in dosing warfarin to achieve target INR value	Other: Active Comparator; Participants were (previously) educated in monitoring the INR values and to adjust the warfarin treatment accordingly to achieve a designated target INR range.; Other Names: self-managing warfarin
Experimental: algorithm-suggested warfarin dosing; algorithm-suggested warfarin dosing, where the participants are provided with a dosage suggestion of their warfarin dosage (calculated dose) to achieve target INR	Other: Experimental; The algorithm is based on a model, which is designed to handle time series of daily warfarin intakes and INR values measured at designated time points. Based on these inputs the model is able to suggest a warfarin maintenance dose to achieve target INR value. Model parameters are initially set to population values and gradually, as data is entered into the model, these parameters become patient specific.; Other Names: algorithm-suggested warfarin dosing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time in therapeutic range	The primary study endpoint, TTR, was calculated according to the Rosendaal method	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Log of the variance growth rate	As a measure of INR variability we used log of the variance growth rate (logVGR) defined by Fihn et al.	6 months

Collaborators and Investigators

• Sponsor: Aalborg University Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: March 2, 2016
• First Submitted That Met QC Criteria: March 10, 2016
• First Posted (Estimate): March 11, 2016

Study Record Updates

• Last Update Posted (Estimate): September 27, 2016
• Last Update Submitted That Met QC Criteria: September 26, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anticoagulants; Warfarin
• Other Study ID Numbers: N-20140036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED