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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04272723
Other study ID # PI2020_843_0014
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 21, 2019
Est. completion date July 1, 2023

Study information

Verified date July 2023
Source Centre Hospitalier Universitaire, Amiens
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 383
Est. completion date July 1, 2023
Est. primary completion date July 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - vascular medicine physicians who refuse to provide consent - vascular medicine physicians who are retired - non-practicing vascular medicine physicians

Study Design


Locations

Country Name City State
France CHU Amiens Amiens

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Inter-practician variability of clinical care of venous thromboembolic according to patient age patient characteristics are : cancer, extreme body weight, severe renal impairment, elderly or pregnant patients, high bleeding risk up to 6 months after inclusion
Secondary Inter-practician variability of clinical care of venous thromboembolic according to patient body weight patient characteristics are : cancer, extreme body weight, severe renal impairment, elderly or pregnant patients, high bleeding risk up to 6 months after inclusion
Secondary Inter-practician variability of clinical care of venous thromboembolic according to patient bleeding risk patient characteristics are : cancer, extreme body weight, severe renal impairment, elderly or pregnant patients, high bleeding risk up to 6 months after inclusion
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