Prospective Trial of a Validated Algorithm for Warfarin Dosing

Not Applicable

Completed

• Conditions: Anticoagulation
• Interventions: Other: Active Comparator; Other: Experimental

• Registration Number: NCT02705976
• Lead Sponsor: Aalborg University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Study First Submitted: 2016-03-02
• Study First Submitted QC: 2016-03-10
• Study First Posted: 2016-03-11
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-26
• Last Update Posted: 2016-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 211

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
self-managing warfarin	Active Comparator	self-managing warfarin patients who are educated in dosing warfarin to achieve target INR value
algorithm-suggested warfarin dosing	Experimental	algorithm-suggested warfarin dosing, where the participants are provided with a dosage suggestion of their warfarin dosage (calculated dose) to achieve target INR

Primary Outcome Measures

Name	Time	Method
Time in therapeutic range	6 months	The primary study endpoint, TTR, was calculated according to the Rosendaal method

Secondary Outcome Measures

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