Prospective Trial of a Validated Algorithm for Warfarin Dosing

Aalborg University Hospital

Status: Completed

Conditions: Anticoagulation

Treatments: Other: Experimental; Other: Active Comparator

Study type: Interventional

Funder types: Other

Identifiers

NCT02705976

N-20140036

Details and patient eligibility

About

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.

Enrollment: 211 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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211 participants in 2 patient groups

self-managing warfarin

Active Comparator group

Description:

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

Treatment:

Other: Active Comparator

algorithm-suggested warfarin dosing

Experimental group

Description:

algorithm-suggested warfarin dosing, where the participants are provided with a dosage suggestion of their warfarin dosage (calculated dose) to achieve target INR

Treatment:

Other: Experimental