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NCT Number: NCT07016542

Cohort for Monitoring Patients With Venous Thromboembolic Disease

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Rouen

Rouen, 76031, France

Location status: Recruiting

Location contact

Sébastien SM MIRANDA, Doctor

CONTACT

[email protected]

02 32 88 90 01 ext. +33

About this study

Several tools have been established and validated to help clinicians assess patients' bleeding risk, notably using the HAS BLED, haemorrage, and more recently the VTE BLED score. This latest score, published very recently, is the only one to have been validated in patients treated with direct oral anticoagulants. At the same time, we have recurrence risk scores such as HERDOO2, which allow us to identify patients at low risk of recurrence.

In order to improve the management of patients with venous thromboembolic disease, multidisciplinary thrombosis RCPs have been established since 2015, bringing together hemostasis specialists, internists, oncologists, and private vascular physicians to assist clinicians in managing complex cases. • Dedicated post-emergency consultations twice a week to streamline outpatient care for less serious patients This study aims to evaluate the effectiveness of these tools: score and RCP in the management of patients with venous thromboembolic disease.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

Thrombosis not meeting the inclusion criteria (cerebral venous thrombosis, mesenteric)

Treatment and study plan

Primary outcomes

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

    Time frame: 12 years

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

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

    Time frame: 12 years

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

Secondary outcomes

  1. Long-term complication rates

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

    Assessment of the occurrence of long-term complications

  2. Long-term complication rates

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

    Assessment of mortality

Study contacts

Contact information is provided by the study sponsor or research team.

David DM MALLET, Director

CONTACT

[email protected]

02 32 88 82 65 ext. +33

Vincent VF FERRANTI, ARC

CONTACT

[email protected]

02 32 88 82 65 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: CoMTEV

Important dates

Study start
2019
Primary completion
2031
Study completion
2032
First posted
Jun 11, 2025
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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