Anti Vitamin K Therapeutic Education

This study is currently recruiting participants.
Verified April 2014 by University Hospital, Montpellier
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01587053
First received: April 12, 2012
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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
AVK
patient with AVK treatment
Other: therapeutic education program

  Eligibility

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

Criteria

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 ClinicalTrials.gov identifier: NCT01587053

Locations
France
Cardio-Pediatric Unit Recruiting
Montpellier, France, 34295
Contact: Pascal Amedro, MD    0467336602    p-amedro@chu-montpellier.fr   
Contact: Sophie Guillaumont, MD    0467336602    s-guillaumont@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: Pascal AMEDRO, MD UH Montpellier
  More Information

No publications provided

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov 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
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014