Cohort for Monitoring Patients With Venous Thromboembolic Disease

NCT07016542 | Recruiting

• 2 other identifiers: 2018/352/OBID RCB : 2018-A02844-51
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

Venous thromboembolic disease is a common pathology in the general population (1.5/1000), the prognosis of which depends in particular on the risk of recurrence. This risk depends essentially on whether the thrombotic episode was provoked or not. Thus, patients who present a thromboembolic event without any contributing factor have a high risk of recurrence, which encourages clinicians to continue anticoagulant treatment for a long time. However, anticoagulant treatment is the leading cause of hospitalization for iatrogenic causes and the leading cause of iatrogenic mortality. The benefit-risk balance of treatment must be evaluated regularly, which requires a good knowledge of the risk factors for thrombotic recurrence and the risk factors for hemorrhage.

Conditions

Venous Thromboembolic Disease

Keywords

risk of thrombotic recurrence; hemorrhagic risk factors

Outcome Measures

Primary Outcomes (2)

• Rate of recurrence in patients treated with venous thromboembolic disease (VTE)

  Evaluation of the number of hospitalizations or consultations for a venous thrombotic recurrence

  12 years

• Rate of bleeding complications in patients treated with venous thromboembolic disease (VTE)

  Evaluation of the number of hospitalizations or consultations for a hemorrhagic complication.

  12 years

Secondary Outcomes (2)

• Long-term complication rates

  At enrollment visit, 6 months, 1 years and each year during 12 years

• Long-term complication rates

  At enrollment visit, 6 months, 1 years and each year during 12 years

Study Arms (1)

Patient having experienced at least one venous thromboembolic episode

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient having experienced at least one venous thromboembolic episode

You may qualify if:

• Any patient over 18 years of age who has experienced at least one venous thromboembolic episode:
• Deep vein thrombosis confirmed by Doppler ultrasound or CT venography,
• Pulmonary embolism confirmed by CT angiography, ventilation/perfusion scan, or confirmed DVT episode with respiratory signs consistent with PE.
• Hospitalization in the Internal Medicine Department
• Consultation by an Internal Medicine physician
• File presented at the thrombosis multidisciplinary meeting

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

University Hospital of Rouen

Rouen, 76031, France

RECRUITING

Study Officials

• Sébastien SM MIRANDA, Doctor

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David DM MALLET, Director

CONTACT

02 32 88 82 65; David.Mallet@chu-rouen.fr

Vincent VF FERRANTI, ARC

CONTACT

02 32 88 82 65; Vincent.Ferranti@chu-rouen.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 11, 2025
• Study Start: November 18, 2019
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): June 1, 2032
• Last Updated: June 11, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP

Locations

FR (1)