NCT02705976

Prospective Trial of a Validated Algorithm for Warfarin Dosing

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 211 (actual)
• Sponsor: Aalborg University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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	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.

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2016-03-11
• Last updated: 2016-09-27