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Model-based Versus Traditional Warfarin Dosing in Children

NCT02475863 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2015-06-22

No results posted yet for this study

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.

Conditions

  • Congenital Heart Defects

Interventions

DEVICE

Warfarin Dosing Aid

A pharmacokinetic/pharmacodynamic model-based dosing algorithm for warfarin

OTHER

Standard Practice

Warfarin dose adjustments according to standard unit protocol

Sponsors & Collaborators

  • University Hospitals, Leicester

    collaborator OTHER

  • De Montfort University

    lead OTHER

Principal Investigators

  • Hussain Mulla, PhD · Univesity Hospitals Leicester NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
1 Day
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-08-31
Completion
2018-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02475863 on ClinicalTrials.gov