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Anti Vitamin K Therapeutic Education

This study has been terminated.
(Difficulty recruiting)
Information provided by (Responsible Party):
University Hospital, Montpellier Identifier:
First received: April 12, 2012
Last updated: February 6, 2017
Last verified: February 2017
The purpose of this study is to measure the INR (International Normalized Ratio) time percentage in the target zone (TTR: time in therapeutic range) of children benefiting from the AVK therapeutic education program.

Condition Intervention
Cardio-vascular Diseases
Other: therapeutic education program

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Anti Vitamin K Therapeutic Education With INR Self Measure Device Within Children From 0 to 18 Years

Resource links provided by NLM:

Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • INR (International Normalized Ratio) time percentage in the target zone (TTR: time in therapeutic range) [ Time Frame: up to 1 year ]

Secondary Outcome Measures:
  • Quality of life questionnaire [ Time Frame: 2 years ]

Enrollment: 57
Actual Study Start Date: April 2012
Study Completion Date: February 2017
Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
patient with AVK treatment
Other: therapeutic education program


Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
children from 0 to 18 years having AVK prescription

Inclusion Criteria:

  • age from 0 to 18 years
  • AVK prescription
  • to accept participating to AVK therapeutic education program
  • informed consent form of parents or legal person

Exclusion Criteria:

  • parents or legal person refusal to enter in the AVK therapeutic education
  Contacts and Locations
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Please refer to this study by its identifier: NCT01587053

Pediatric and Congénital Cardiology Department
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Principal Investigator: Pascal AMEDRO, MD PhD Pediatric and Congénital Cardiology Department, UH Montpellier
  More Information

Responsible Party: University Hospital, Montpellier Identifier: NCT01587053     History of Changes
Other Study ID Numbers: 8745
Study First Received: April 12, 2012
Last Updated: February 6, 2017

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Vitamin K
Antivitamins K
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs
Anticoagulants processed this record on April 28, 2017