NCT01587053

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 27, 2012

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

December 2, 2020

Status Verified

November 1, 2020

Enrollment Period

4.8 years

First QC Date

April 12, 2012

Last Update Submit

November 30, 2020

Conditions

Cardio-vascular Diseases

Outcome Measures

Primary Outcomes (1)

  • INR (International Normalized Ratio) time percentage in the target zone (TTR: time in therapeutic range)

    up to 1 year

Secondary Outcomes (1)

  • Quality of life questionnaire

    2 years

Study Arms (1)

AVK

patient with AVK treatment

Other: therapeutic education program

Interventions

therapeutic education programOTHER
AVK

Eligibility Criteria

Age1 Day - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

children from 0 to 18 years having AVK prescription

You may qualify if:

  • age from 0 to 18 years
  • AVK prescription
  • to accept participating to AVK therapeutic education program
  • informed consent form of parents or legal person

You may not qualify if:

  • parents or legal person refusal to enter in the AVK therapeutic education

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Montpellier, 34295, France

Location

Related Publications (1)

  • 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.

    PMID: 33069639RESULT

Study Officials

  • Pascal AMEDRO, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2012

First Posted

April 27, 2012

Study Start

April 1, 2012

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

December 2, 2020

Record last verified: 2020-11

Locations

FR(1)