Model-based Versus Traditional Warfarin Dosing in Children (WATCH)

De Montfort University

Status: Unknown

Conditions: Congenital Heart Defects

Treatments: Other: Standard Practice; Device: Warfarin Dosing Aid

Study type: Interventional

Funder types: Other

Identifiers

NCT02475863

DMU-1527

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 1 day to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: -Children from birth up to 18 years with congenital heart disease who have been treated or to be treated with warfarin after undergoing reconstructive heart surgery at Glenfield Hospital, Leicester, United Kingdom.

Exclusion Criteria:

1. Patients aged over 18 years who are treated as 'adults'.
2. Children who refuse assent, parents who refuse consent.
3. Any significant disease or disorder which, in the opinion of the direct care team, may either put the participant at risk because of study participation or adversely affect the participants' ability to participate in the study.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

Warfarin dosing aid

Experimental group

Description:

A pharmacokinetic/pharmacodynamic model-based dosing algorithm for warfarin.

Treatment:

Device: Warfarin Dosing Aid

Standard practice

Active Comparator group

Description:

Dosing adjustments according to the normal unit protocol

Treatment:

Other: Standard Practice