Anti Vitamin K Therapeutic Education

NCT ID: NCT01587053

Last Updated: 2020-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2017-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Cardio-vascular Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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AVK

patient with AVK treatment

therapeutic education program

Intervention Type OTHER

Interventions

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therapeutic education program

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pascal AMEDRO, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital

Locations

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Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital

Montpellier, , France

Site Status

Countries

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France

References

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Abassi H, Bajolle F, Werner O, Auer A, Marquina A, Mura T, Lavastre K, Guillaumont S, Manna F, Auquier P, Bonnet D, Amedro P. Health-related quality of life correlates with time in therapeutic range in children on anticoagulants with International Normalised Ratio self-monitoring. Arch Cardiovasc Dis. 2020 Dec;113(12):811-820. doi: 10.1016/j.acvd.2020.05.022. Epub 2020 Oct 14.

Reference Type RESULT
PMID: 33069639 (View on PubMed)

Other Identifiers

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8745

Identifier Type: -

Identifier Source: org_study_id