Model-based Versus Traditional Warfarin Dosing in Children
NCT ID: NCT02475863
Last Updated: 2015-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
45 participants
INTERVENTIONAL
2015-08-31
2018-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
International Multi Centre Randomized Clinical Trial Of Anticoagulation In Children Following Fontan Procedures
NCT00182104
Safety of Dabigatran Etexilate in Blood Clot Prevention in Children
NCT02197416
Comparison of Warfarin Dosing Using Decision Model Versus Pharmacogenetic Algorithm
NCT00511173
Pot-Kast: Thrombosis Prophylaxis After Knee Arthroscopy
NCT01542723
Prospective Trial of a Validated Algorithm for Warfarin Dosing
NCT02705976
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Warfarin dosing aid
A pharmacokinetic/pharmacodynamic model-based dosing algorithm for warfarin.
Warfarin Dosing Aid
A pharmacokinetic/pharmacodynamic model-based dosing algorithm for warfarin
Standard practice
Dosing adjustments according to the normal unit protocol
Standard Practice
Warfarin dose adjustments according to standard unit protocol
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Warfarin Dosing Aid
A pharmacokinetic/pharmacodynamic model-based dosing algorithm for warfarin
Standard Practice
Warfarin dose adjustments according to standard unit protocol
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Exclusion Criteria
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.
1 Day
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospitals, Leicester
OTHER
De Montfort University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hussain Mulla, PhD
Role: PRINCIPAL_INVESTIGATOR
Univesity Hospitals Leicester NHS Trust
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DMU-1527
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.