Anti Vitamin K Therapeutic Education

The recruitment status of this study is unknown because the information has not been verified recently.
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 ] [ 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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 processed this record on May 26, 2016