Anti Vitamin K Therapeutic Education

This study is currently recruiting participants.
Verified April 2014 by University Hospital, Montpellier
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life questionnaire [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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
Please refer to this study by its identifier: NCT01587053

Cardio-Pediatric Unit Recruiting
Montpellier, France, 34295
Contact: Pascal Amedro, MD    0467336602   
Contact: Sophie Guillaumont, MD    0467336602   
Sponsors and Collaborators
University Hospital, Montpellier
Principal Investigator: Pascal AMEDRO, MD UH Montpellier
  More Information

No publications provided

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
Health Authority: France: Committee for the Protection of Personnes

Additional relevant MeSH terms:
Cardiovascular Diseases
Vascular Diseases
Vitamin K
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Therapeutic Uses processed this record on April 23, 2014