Congenital Heart DefectsWATCHNCT02475863
Model-based Versus Traditional Warfarin Dosing in Children
A study testing Warfarin Dosing Aid and Standard Practice in people with Congenital Heart Defects, run by De Montfort University.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Congenital Heart Defects
- What is being tested?
- Warfarin Dosing Aid and Standard Practice
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- Patients aged over 18 years who are treated as 'adults'.
- Children who refuse assent, parents who refuse consent.
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: A Study to Compare Model-based Warfarin Dosing to the Traditional Approach in Children After Congenital Heart Surgery at Glenfield Hospital, Leicester
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.
Read the 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
- Being tested
- Warfarin Dosing Aid, Standard Practice
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warfarin Dosing AidDevice
A pharmacokinetic/pharmacodynamic model-based dosing algorithm for warfarin
Standard PracticeOther
Warfarin dose adjustments according to standard unit protocol
| Study group | Role | What they receive |
|---|---|---|
| Warfarin dosing aid | Experimental | A pharmacokinetic/pharmacodynamic model-based dosing algorithm for warfarin. Receives: Device: Warfarin Dosing Aid |
| Standard practice | Active comparator | Dosing adjustments according to the normal unit protocol Receives: Other: Standard Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference between the model based and traditional warfarin dosing method in International Normalised Ratio (INR) response.
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.
Measured: 6 months for warfarin naiive patients and 12 months for patients already on warfarin therapy.
Secondary outcomes (3)
Medical staff perceptions of value of warfarin dosing aid
Interviews with medical staff will be conducted
Measured: Within six months of end of period of data collection
Patients or carers 'lived experience' of monitoring warfarin dosing and INR
Interviews will be conducted with patients and or carers
Measured: Within six months of end of cross-over trial
The incidence of warfarin-related adverse events, bleeding and bruising, by recording on symptom diary cards
Measured: 6 months for warfarin naiive patients and 12 months for patients already on warfarin therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2016 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DefectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- De Montfort University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals, Leicester
- Responsible party
- Sponsor
- Investigators
- Hussain Mulla, PhD, Principal investigator, Univesity Hospitals Leicester NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02475863
- Sponsor's protocol ID
- DMU-1527
- Acronym
- WATCH
- Status last verified
- Jun 2015
- First submitted
- 12 Jun 2015
- Last updated
- 22 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Compare Model-based Warfarin Dosing to the Traditional Approach in Children After Congenital Heart Surgery at Glenfield Hospital, Leicester
- ClinicalTrials.gov ID
- NCT02475863
- Acronym / sponsor ID
- WATCH / DMU-1527
- Conditions
- Congenital Heart Defects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- De Montfort UniversityUniversity, hospital or other
- Collaborators
- University Hospitals, Leicester
- Study start
- Aug 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 19 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Warfarin dosing aid | Experimental | Device: Warfarin Dosing AidA pharmacokinetic/pharmacodynamic model-based dosing algorithm for warfarin. |
| Standard practice | Active comparator | Other: Standard PracticeDosing adjustments according to the normal unit protocol |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Patients aged over 18 years who are treated as 'adults'.
- Children who refuse assent, parents who refuse consent.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Warfarin Dosing AidA pharmacokinetic/pharmacodynamic model-based dosing algorithm for warfarin | Device | Warfarin dosing aid |
| Standard PracticeWarfarin dose adjustments according to standard unit protocol | Other | Standard practice |
Primary outcome
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.
3 secondary outcomes
Medical staff perceptions of value of warfarin dosing aid
Time frame: Within six months of end of period of data collection
Patients or carers 'lived experience' of monitoring warfarin dosing and INR
Time frame: Within six months of end of cross-over trial
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hussain Mulla, PhD principal investigator
Univesity Hospitals Leicester NHS Trust
Questions about this trial
What is this clinical trial studying?
A study testing Warfarin Dosing Aid and Standard Practice in people with Congenital Heart Defects, run by De Montfort University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hussain Mulla, PhD (0116 2563323, hussain.mulla@uhl-tr.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2015; AzTrials last refreshed its copy on 30 Oct 2026.