NCT04272723

Brief Summary

In France, venous thromboembolic (VTE) disease is usually managed by vascular medicine physicians (VMP). The national OPTIMEV study, conducted more than 12 years ago among VMP practicing in hospital and in the community described the management of VTE in routine clinical practice. Since then a large number of practice changing studies have been published. This includes trials that have validated the use of direct oral anticoagulants (DOAC), the new standard of care of VTE, as per new national and international guidelines. Management of VTE in 2019 appears to be significantly different from the one that prevailed more than 10 years ago when the last national survey was conducted. It is therefore important to have an update on the routine clinical practice management of VTE by VMP. In this perspective the investigators aim to conduct a national survey among VMP practicing in France

Trial Health

87
On Track

Trial Health Score

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

Enrollment
383

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

August 21, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

July 12, 2023

Status Verified

July 1, 2023

Enrollment Period

3.9 years

First QC Date

February 13, 2020

Last Update Submit

July 11, 2023

Conditions

Keywords

SurveyVenous ThromboembolismDeep Vein ThrombosisPulmonary EmbolismAnticoagulantClinical PracticeTherapeutic management

Outcome Measures

Primary Outcomes (1)

  • Inter-practician variability of clinical care of venous thromboembolic in routine clinical practice

    The variation in venous thromboembolic management in routine clinical practice is assessed by analysing the management of the 5 consecutive acute venous thromboembolic patients reported by each participating physician

    up to 3 months after inclusion

Secondary Outcomes (3)

  • Inter-practician variability of clinical care of venous thromboembolic according to patient age

    up to 6 months after inclusion

  • Inter-practician variability of clinical care of venous thromboembolic according to patient body weight

    up to 6 months after inclusion

  • Inter-practician variability of clinical care of venous thromboembolic according to patient bleeding risk

    up to 6 months after inclusion

Study Arms (2)

VMP members of the SFMV

VMP (vascular medicine physicians) members of the SFMV (French Society of Vascular Medicine )

VMP registered as willing to do medical research

VMP (vascular medicine physicians) registered as willing to do medical research

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Vascular medicine physicians (VMP) practicing in the hospital and in the community settings. Participating VMP will prospectively collect data on the management of incident venous thromboembolic (VTE) disease cases. After that, vascular medicine physicians will answer a phone questionnaire on their general VTE management

You may qualify if:

  • vascular medicine physicians who are active members of the SFMV (French Society of Vascular Medicine)
  • vascular medicine physicians registered as willing to do medical research

You may not qualify if:

  • vascular medicine physicians who refuse to provide consent
  • vascular medicine physicians who are retired
  • non-practicing vascular medicine physicians

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80480, France

Location

MeSH Terms

Conditions

Venous ThromboembolismVenous ThrombosisPulmonary Embolism

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesThrombosisLung DiseasesRespiratory Tract DiseasesEmbolism

Study Officials

  • Simon Soudet, MD

    CHU Amiens

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 13, 2020

First Posted

February 17, 2020

Study Start

August 21, 2019

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

July 12, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations