Prospective Trial of a Validated Algorithm for Warfarin Dosing

NCT ID: NCT02705976

Last Updated: 2016-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 211 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-05-31

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.

Conditions

Anticoagulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

self-managing warfarin

self-managing warfarin patients who are educated in dosing warfarin to achieve target INR value

Group Type: ACTIVE_COMPARATOR

Active Comparator

Intervention Type: OTHER

Participants were (previously) educated in monitoring the INR values and to adjust the warfarin treatment accordingly to achieve a designated target INR range.

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

Group Type: EXPERIMENTAL

Experimental

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

algorithm-suggested warfarin dosing; self-managing warfarin

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aalborg University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Peter Brønnum

Postdoc, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

N-20140036

Identifier Type: -

Identifier Source: org_study_id