Prospective Trial of a Validated Algorithm for Warfarin Dosing

Sponsor

Aalborg University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02705976

Collaborator

(none)

211

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anticoagulation	Other: Experimental Other: Active Comparator	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

211 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

Prospective Trial of a Validated Algorithm for Warfarin Dosing

Study Start Date :

Sep 1, 2014

Actual Primary Completion Date :

May 1, 2015

Actual Study Completion Date :

May 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Aalborg University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peter Brønnum, Postdoc, PhD, Aalborg University Hospital

ClinicalTrials.gov Identifier:

NCT02705976

Other Study ID Numbers:

N-20140036

First Posted:

Mar 11, 2016

Last Update Posted:

Sep 27, 2016

Last Verified:

Sep 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Additional relevant MeSH terms:

Warfarin

Study Results

No Results Posted as of Sep 27, 2016