NCT02475863

Model-based Versus Traditional Warfarin Dosing in Children

A Study to Compare Model-based Warfarin Dosing to the Traditional Approach in Children After Congenital Heart Surgery at Glenfield Hospital, Leicester

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: De Montfort University · Academic / Other
• Sex: All
• Age: 1 Day – 18 Years
• Healthy volunteers: Not accepted

Summary

This study compares the clinical effectiveness of a new algorithm (model-based warfarin dosing) with standard practice (doctor's own judgement and intuition) designed to determine the most appropriate anticoagulant dose of warfarin in children after congenital heart surgery.

Detailed description

Warfarin is widely used in children after heart surgery in order to prevent complications that may arise due to blood clots forming in unwanted places - for example in the brain causing a stroke. If too little warfarin is given, there is a risk that clots may form. If the dose is too high, bleeding will result. Traditionally, the approach to dosing warfarin in children has been to select a starting dose according to standard guidelines and to then adjust the doses for each child by monitoring the INR (which measures how quickly blood clots). However, a person's make up as well as external factors, such as age, weight, diet and genetics can affect warfarin dosing and this makes controlling the dose and hence controlling the INR, more difficult. Recently however, a more sophisticated dosing model has been developed by researchers which takes into account some of these factors. The model is designed to help doctors select the best dose of warfarin for children by individualising prescriptions. The aim of the proposed research is, therefore, to compare the model based warfarin dosing with the traditional approach to warfarin dosing in children who have undergone congenital heart surgery. The research will involve children who are started on warfarin for the first time and also children who are already receiving ongoing warfarin therapy.

Conditions

• Congenital Heart Defects

Interventions

Type	Name	Description
DEVICE	Warfarin Dosing Aid	A pharmacokinetic/pharmacodynamic model-based dosing algorithm for warfarin
OTHER	Standard Practice	Warfarin dose adjustments according to standard unit protocol

Timeline

• Start date: 2015-08-01
• Primary completion: 2016-08-01
• Completion: 2018-01-01
• First posted: 2015-06-19
• Last updated: 2015-06-22