Prospective Trial of a Validated Algorithm for Warfarin Dosing

Anticoagulation Clinical Trial

Official title:

Prospective Trial of a Validated Algorithm for Warfarin Dosing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02705976
• Other study ID #: N-20140036
• Status: Completed
• Phase: N/A
• First received: March 2, 2016
• Last updated: September 26, 2016
• Start date: September 2014
• Est. completion date: May 2015

Study information

• Verified date: September 2016
• Source: Aalborg Universitetshospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The National Committee on Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anticoagulation

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg Universitetshospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time in therapeutic range	The primary study endpoint, TTR, was calculated according to the Rosendaal method	6 months	Yes
Secondary	Log of the variance growth rate	As a measure of INR variability we used log of the variance growth rate (logVGR) defined by Fihn et al.	6 months	Yes