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

• ClinicalTrials.gov Identifier: NCT02188056
• Recruitment Status: Unknown
• First Posted: July 11, 2014
• Last Update Posted: October 21, 2014
• Sponsor: University Hospital, Strasbourg, France
• 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
• 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

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

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