Observational Prospectif Monocentric Registry of Patients Suffering From VIE

Venous Thromboembolic Disease Clinical Trial

— REMOTEV  

Official title:

Observational Prospectif Monocentric Registry of Patients Suffering From VIE

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02188056
• Other study ID #: 003-14
• Status: Not yet recruiting
• Phase: N/A
• First received: July 3, 2014
• Last updated: October 20, 2014
• Start date: October 2014

Study information

• Verified date: July 2014
• Source: University Hospital, Strasbourg, France
• Contact: Dominique STEPHAN, MD, PhD
• Phone: 33.3.69.55.09.52
• Email: dominique.stephan[@]chru-strasbourg.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Patients with an episode of VTE (DVT and / or PE) have a mortality rate of 16-21% at 1 year after diagnosis. Morbidity associated with VTE is marked by the risk of recurrence, estimated at 30% and estimated at 29% after 8 years of follow post-thrombotic syndrome. For a number of these patients, risk factors have been identified (congenital or acquired thrombophilia, cancer, postpartum, surgery, prolonged immobilization, etc..). In 25-50% of cases, the etiology remains unknown, justifying the need for well-conducted studies to determine other potential risk factors. In addition, the expansion of treatment options with the arrival on the market of new direct oral anticoagulants, allows comparative studies on the effectiveness and frequency of adverse events for each treatment.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• diagnosis of venous thromboembolism established by a validated test (venous Doppler ultrasound of the lower limbs, pulmonary angiography, lung scan ventilation / perfusion),

• diagnosis of venous thromboembolism made within 15 days,

• the previous inclusion in the register (outpatient or inpatient)

Exclusion Criteria:

• person doesn't wish to participate in this study

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolic Disease

Locations

Country	Name	City	State
France	Service Des Maladies Vasculaires - Hta - Nhc	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of recurrent thromboembolic		at 1 year post-diagnosis	No
Primary	bleeding complications incidence		at 1 year post-diagnosis	No