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Observational Prospectif Monocentric Registry of Patients Suffering From VIE (REMOTEV)

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ClinicalTrials.gov Identifier: NCT02188056
Recruitment Status : Unknown
Verified July 2014 by University Hospital, Strasbourg, France.
Recruitment status was:  Not yet recruiting
First Posted : July 11, 2014
Last Update Posted : October 21, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Study Description
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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
Venous Thromboembolic Disease

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Observational Prospectif Monocentric Registry of Patients Suffering From VIE
Study Start Date : October 2014
Estimated Primary Completion Date : August 2017
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. incidence of recurrent thromboembolic [ Time Frame: at 1 year post-diagnosis ]
  2. bleeding complications incidence [ Time Frame: at 1 year post-diagnosis ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with a venous thromboembolic event, hospitalized in the Department of Vascular Diseases and Hypertension, UF 1311 will included in the registry prospectively.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188056


Contacts
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Contact: Dominique STEPHAN, MD, PhD 33.3.69.55.09.52 dominique.stephan@chru-strasbourg.fr

Locations
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France
Service Des Maladies Vasculaires - Hta - Nhc
Strasbourg, France, 67091
Contact: Dominique STEPHAN, MD, PhD    33.3.69.55.09.52    Dominique.Stephan@chru-strasbourg.fr   
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
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Principal Investigator: Dominique STEPHAN, MD, PhD Strasbourg University Hospital, France
More Information
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Additional Information:

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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02188056    
Other Study ID Numbers: 003-14
First Posted: July 11, 2014    Key Record Dates
Last Update Posted: October 21, 2014
Last Verified: July 2014
Keywords provided by University Hospital, Strasbourg, France:
Venous
Thromboembolic
Pulmonary embolism
Additional relevant MeSH terms:
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Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases