University Hospital of Rouen
Rouen, 76031, France
Location status: Recruiting
NCT Number: NCT07016542
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Rouen, 76031, France
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Thrombosis not meeting the inclusion criteria (cerebral venous thrombosis, mesenteric)
Time frame: 12 years
Evaluation of the number of hospitalizations or consultations for a venous thrombotic recurrence
Time frame: 12 years
Evaluation of the number of hospitalizations or consultations for a hemorrhagic complication.
Time frame: At enrollment visit, 6 months, 1 years and each year during 12 years
Assessment of the occurrence of long-term complications
Time frame: At enrollment visit, 6 months, 1 years and each year during 12 years
Assessment of mortality
Contact information is provided by the study sponsor or research team.
David DM MALLET, Director
CONTACT
02 32 88 82 65 ext. +33
Vincent VF FERRANTI, ARC
CONTACT
02 32 88 82 65 ext. +33
University Hospital, Rouen
Other
Acronym: CoMTEV
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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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