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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

Tracking Information
First Submitted Date July 3, 2014
First Posted Date July 11, 2014
Last Update Posted Date October 21, 2014
Study Start Date October 2014
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 9, 2014)
  • incidence of recurrent thromboembolic [ Time Frame: at 1 year post-diagnosis ]
  • bleeding complications incidence [ Time Frame: at 1 year post-diagnosis ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Observational Prospectif Monocentric Registry of Patients Suffering From VIE
Official Title Observational Prospectif Monocentric Registry of Patients Suffering From VIE
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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Not Provided
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.
Condition Venous Thromboembolic Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: July 9, 2014)
300
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02188056
Other Study ID Numbers 003-14
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Strasbourg, France
Study Sponsor University Hospital, Strasbourg, France
Collaborators Not Provided
Investigators
Principal Investigator: Dominique STEPHAN, MD, PhD Strasbourg University Hospital, France
PRS Account University Hospital, Strasbourg, France
Verification Date July 2014