Incidence of Venous Thromboembolism and Professional Prac... | NCT02895971

Studies
Incidence of Venous Thromboembolism and Professional Practices in Brest Area

NCT02895971

Sponsor

University Hospital, Brest

Status

Completed

Last Update Posted

Jul 5, 2017Actual

Enrollment

1,416Actual

Phase

Not provided

Conditions

Venous Thromboembolism

Interventions

Not provided

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

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 4, 2013Actual

Primary Completion Date

Jun 30, 2017Actual

Completion Date

Jun 30, 2017Actual

First Submitted Date

Aug 29, 2016

First Submission Date that Met QC Criteria

Sep 6, 2016

First Posted Date

Sep 12, 2016Estimated

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

Jul 3, 2017

Last Update Posted Date

Jul 5, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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 aim of this study estimate VTE incidence. Investigators prospectively record all cases of symptomatic pulmonary embolism (PE) and deep vein thrombosis (DVT) of the lower limbs diagnosed between March 1, 2013 and February 28, 2014 in hospitals and in the community.

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

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

1,416Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Gathering information about potential factors predisposing Thromboembolic disease and treatments undertaken.	After two years, all medication given to the patient to treat his initial VTE will be recorded, as well as the ongoing of thromboembolic disease	two years after VTE

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

symptomatic pulmonary embolism (PE) and deep vein thrombosis (DVT) diagnosis confirmed
Patient living in Brest area from time of diagnosis

Exclusion Criteria:

invalid diagnosis
asymptomatic event
Main residence patient out of Brest area.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patient with venous thromboembolism

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
CHRU de Brest		Brest		29609	France

Condition Browse Module

MeSH Terms

ID	Term
D054556	Venous Thromboembolism

Ancestor Terms

ID	Term
D013923	Thromboembolism
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided