Model-based Versus Traditional Warfarin Dosing in Children
WATCH
A Study to Compare Model-based Warfarin Dosing to the Traditional Approach in Children After Congenital Heart Surgery at Glenfield Hospital, Leicester
1 other identifier
interventional
45
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2015
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2015
CompletedFirst Posted
Study publicly available on registry
June 19, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedJune 22, 2015
June 1, 2015
1 year
June 12, 2015
June 19, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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.
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
Within six months of end of period of data collection
Patients or carers 'lived experience' of monitoring warfarin dosing and INR
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
6 months for warfarin naiive patients and 12 months for patients already on warfarin therapy.
Study Arms (2)
Warfarin dosing aid
EXPERIMENTALA pharmacokinetic/pharmacodynamic model-based dosing algorithm for warfarin.
Standard practice
ACTIVE COMPARATORDosing adjustments according to the normal unit protocol
Interventions
A pharmacokinetic/pharmacodynamic model-based dosing algorithm for warfarin
Warfarin dose adjustments according to standard unit protocol
Eligibility Criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- De Montfort Universitylead
- University Hospitals, Leicestercollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hussain Mulla, PhD
Univesity Hospitals Leicester NHS Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2015
First Posted
June 19, 2015
Study Start
August 1, 2015
Primary Completion
August 1, 2016
Study Completion
January 1, 2018
Last Updated
June 22, 2015
Record last verified: 2015-06