Prospective Trial of a Validated Algorithm for Warfarin Dosing

NCT02705976 | Completed

• 1 other identifier: N-20140036
• Study Type: interventional
• Target: 211
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Time in therapeutic range

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

  6 months

Secondary Outcomes (1)

• Log of the variance growth rate

  6 months

Study Arms (2)

self-managing warfarin

ACTIVE COMPARATOR

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

Other: Active Comparator

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

Other: Experimental

Interventions

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.

Also known as: algorithm-suggested warfarin dosing

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.

Also known as: self-managing warfarin

self-managing warfarin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aalborg University Hospital: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoc, PhD

Study Record Dates

• First Submitted: March 2, 2016
• First Posted: March 11, 2016
• Study Start: September 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: September 27, 2016

Record last verified: 2016-09