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Anti Vitamin K Therapeutic Education

This study has been terminated.
(Difficulty recruiting)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01587053
First Posted: April 27, 2012
Last Update Posted: February 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Montpellier
  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 ]

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
AVK
patient with AVK treatment
Other: therapeutic education program

  Eligibility

Information from the National Library of Medicine

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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
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01587053


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

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01587053     History of Changes
Other Study ID Numbers: 8745
First Submitted: April 12, 2012
First Posted: April 27, 2012
Last Update Posted: February 8, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Vitamin K
Antivitamins K
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Anticoagulants