NCT02188056

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 11, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
Last Updated

September 5, 2025

Status Verified

July 1, 2014

Enrollment Period

2.9 years

First QC Date

July 3, 2014

Last Update Submit

September 4, 2025

Conditions

Venous Thromboembolic Disease

Keywords

VenousThromboembolicPulmonary embolism

Outcome Measures

Primary Outcomes (2)

  • incidence of recurrent thromboembolic

    at 1 year post-diagnosis

  • bleeding complications incidence

    at 1 year post-diagnosis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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,

You may not qualify if:

  • person doesn't wish to participate in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service Des Maladies Vasculaires - Hta - Nhc

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Dominique STEPHAN, MD, PhD

    Strasbourg University Hospital, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2014

First Posted

July 11, 2014

Study Start

October 1, 2014

Primary Completion

August 31, 2017

Study Completion

August 31, 2017

Last Updated

September 5, 2025

Record last verified: 2014-07

Locations

FR(1)