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REMOTEV: Observational Prospectif Monocentric Registry of Patients Suffering From VIE

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Unknown status
CT.gov ID
NCT02188056
Collaborator
(none)
300
Enrollment
1
Location

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Observational Prospectif Monocentric Registry of Patients Suffering From VIE
    Study Start Date :
    Oct 1, 2014
    Anticipated Primary Completion Date :
    Aug 1, 2017

    Outcome Measures

    Primary Outcome Measures

    1. incidence of recurrent thromboembolic [at 1 year post-diagnosis]

    2. bleeding complications incidence [at 1 year post-diagnosis]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service Des Maladies Vasculaires - Hta - Nhc Strasbourg France 67091

    Sponsors and Collaborators

    • University Hospital, Strasbourg, France

    Investigators

    • Principal Investigator: Dominique STEPHAN, MD, PhD, Strasbourg University Hospital, France

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Strasbourg, France
    ClinicalTrials.gov Identifier:
    NCT02188056
    Other Study ID Numbers:
    • 003-14
    First Posted:
    Jul 11, 2014
    Last Update Posted:
    Oct 21, 2014
    Last Verified:
    Jul 1, 2014
    Keywords provided by University Hospital, Strasbourg, France
    Venous
    Thromboembolic
    Pulmonary embolism
    Additional relevant MeSH terms:
    Thromboembolism

    Study Results

    No Results Posted as of Oct 21, 2014