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.

Completed

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Key information

Conditions

Anticoagulation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Experimental

Other

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

Active comparator

Other

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

Primary outcomes

Time in therapeutic range

Time frame: 6 months

The primary study endpoint, TTR, was calculated according to the Rosendaal method

Secondary outcomes

Log of the variance growth rate

Time frame: 6 months

As a measure of INR variability we used log of the variance growth rate (logVGR) defined by Fihn et al.

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Mar 11, 2016
Registry last updated: Sep 27, 2016

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.

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Completed