Anti Vitamin K Therapeutic Education | NCT01587053

Studies
Anti Vitamin K Therapeutic Education

NCT01587053

Sponsor

University Hospital, Montpellier

Status

Terminated

Last Update Posted

Dec 2, 2020Actual

Enrollment

57Actual

Phase

Not provided

Conditions

Cardio-vascular Diseases

Interventions

therapeutic education program

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficulty recruiting

Expanded Access Info

Start Date

Apr 2012Actual

Primary Completion Date

Feb 2017Actual

Completion Date

Feb 2017Actual

First Submitted Date

Apr 12, 2012

First Submission Date that Met QC Criteria

Apr 25, 2012

First Posted Date

Apr 27, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 30, 2020

Last Update Posted Date

Dec 2, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

57Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AVK		patient with AVK treatment	Other: therapeutic education program

Interventions

Name	Type	Description	Arm Group Labels	Other Names
therapeutic education program	Other		AVK

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
INR (International Normalized Ratio) time percentage in the target zone (TTR: time in therapeutic range)		up to 1 year

Secondary Outcomes

Measure	Description	Time Frame
Quality of life questionnaire		2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

children from 0 to 18 years having AVK prescription

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pascal AMEDRO, MD, PhD	Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital		Montpellier		34295	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33069639	Result	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.