Model-based versus traditional warfarin dosing in children
Research type
Research Study
Full title
An observational study to compare model-based warfarin dosing to the traditional approach in children after congenital heart surgery at Glenfield Hospital, Leicester.
IRAS ID
171407
Contact name
Hussain Mulla
Contact email
Sponsor organisation
De Montfort University
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 3 days
Research summary
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. The research will compare how effective the two methods are by studying factors like the time it takes to reach the therapeutic (target) range, the proportion of INR measurements and time spent in the therapeutic range. The study will also try to find out the views of children, parents and medical staff about the new warfarin dosing method and how best to encourage the safe and correct use of warfarin.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
15/EM/0325
Date of REC Opinion
26 Aug 2015
REC opinion
Favourable Opinion