Anti Vitamin K Therapeutic Education

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2014 by University Hospital, Montpellier.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
University Hospital, Montpellier Identifier:
First received: April 12, 2012
Last updated: April 14, 2014
Last verified: April 2014
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 ]

Estimated Enrollment: 80
Study Start Date: April 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2015 (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

Cardio-Pediatric Unit
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Principal Investigator: Pascal AMEDRO, MD UH Montpellier
  More Information

Responsible Party: University Hospital, Montpellier Identifier: NCT01587053     History of Changes
Other Study ID Numbers: UF8745 
Study First Received: April 12, 2012
Last Updated: April 14, 2014

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 January 19, 2017