Anti Vitamin K Therapeutic Education
This study is currently recruiting participants.
Verified August 2012 by University Hospital, Montpellier
Sponsor:
University Hospital, Montpellier
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01587053
First received: April 12, 2012
Last updated: August 10, 2012
Last verified: August 2012
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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 2016 (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: | August 10, 2012 |
| 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 May 22, 2013