Working… Menu

Prospective Trial of a Validated Algorithm for Warfarin Dosing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02705976
Recruitment Status : Completed
First Posted : March 11, 2016
Last Update Posted : September 27, 2016
Information provided by (Responsible Party):
Peter Brønnum, Aalborg University Hospital

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 Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : September 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

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 Name: 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 Name: algorithm-suggested warfarin dosing

Primary Outcome Measures :
  1. Time in therapeutic range [ Time Frame: 6 months ]
    The primary study endpoint, TTR, was calculated according to the Rosendaal method

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Layout table for additonal information
Responsible Party: Peter Brønnum, Postdoc, PhD, Aalborg University Hospital Identifier: NCT02705976     History of Changes
Other Study ID Numbers: N-20140036
First Posted: March 11, 2016    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
Layout table for MeSH terms