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Trial record 39 of 231 for:    warfarin AND International

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
Sponsor:
Collaborator:
University Hospitals, Leicester
Information provided by (Responsible Party):
De Montfort University

Brief 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.

Condition or disease Intervention/treatment Phase
Congenital Heart Defects Device: Warfarin Dosing Aid Other: Standard Practice Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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. ]


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Hussain Mulla, PhD 0116 2563323 hussain.mulla@uhl-tr.nhs.uk
Contact: Peter Rivers, PhD 0116 2577039 ext 7039 privers@dmu.ac.uk

Sponsors and Collaborators
De Montfort University
University Hospitals, Leicester
Investigators
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Principal Investigator: Hussain Mulla, PhD Univesity Hospitals Leicester NHS Trust

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Responsible Party: De Montfort University
ClinicalTrials.gov Identifier: NCT02475863     History of Changes
Other Study ID Numbers: DMU-1527
First Posted: June 19, 2015    Key Record Dates
Last Update Posted: June 22, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Warfarin
Anticoagulants