Model-based Versus Traditional Warfarin Dosing in Children (WATCH)
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|ClinicalTrials.gov Identifier: NCT02475863|
Recruitment Status : Unknown
Verified June 2015 by De Montfort University.
Recruitment status was: Not yet recruiting
First Posted : June 19, 2015
Last Update Posted : June 22, 2015
|Condition or disease||Intervention/treatment||Phase|
|Congenital Heart Defects||Device: Warfarin Dosing Aid Other: Standard Practice||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Study to Compare Model-based Warfarin Dosing to the Traditional Approach in Children After Congenital Heart Surgery at Glenfield Hospital, Leicester|
|Study Start Date :||August 2015|
|Estimated Primary Completion Date :||August 2016|
|Estimated Study Completion Date :||January 2018|
Experimental: Warfarin dosing aid
A pharmacokinetic/pharmacodynamic model-based dosing algorithm for warfarin.
Device: Warfarin Dosing Aid
A pharmacokinetic/pharmacodynamic model-based dosing algorithm for warfarin
Active Comparator: Standard practice
Dosing adjustments according to the normal unit protocol
Other: Standard Practice
Warfarin dose adjustments according to standard unit protocol
- The difference between the model based and traditional warfarin dosing method in International Normalised Ratio (INR) response. [ Time Frame: 6 months for warfarin naiive patients and 12 months for patients already on warfarin therapy. ]INR response includes: Time taken (days per patient) to achieve stable anticoagulation within the desired therapeutic range (TR), number and percentage of INR measurements within the TR, Time in TR, and frequency of INR measurements (number of INR measurements per month) per patient.
- Medical staff perceptions of value of warfarin dosing aid [ Time Frame: Within six months of end of period of data collection ]Interviews with medical staff will be conducted
- Patients or carers 'lived experience' of monitoring warfarin dosing and INR [ Time Frame: Within six months of end of cross-over trial ]Interviews will be conducted with patients and or carers
- The incidence of warfarin-related adverse events, bleeding and bruising, by recording on symptom diary cards [ Time Frame: 6 months for warfarin naiive patients and 12 months for patients already on warfarin therapy. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02475863
|Contact: Hussain Mulla, PhD||0116 firstname.lastname@example.org|
|Contact: Peter Rivers, PhD||0116 2577039 ext email@example.com|
|Principal Investigator:||Hussain Mulla, PhD||Univesity Hospitals Leicester NHS Trust|