Clinical trial NCT06073366: Long-term Surveillance of Patients With Venous Thromboembolism: a Nationwide Prospective Cohort Study
Official title: Long-term Surveillance of Patients With Venous Thromboembolism: a Nationwide Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Venous Thromboembolism
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2023-10-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients diagnosed with venous thromboembolism will be eligible to participate in the study.

Brief summary: This observational study aims to establish a prospective nationwide cohort of venous thromboembolism. The main questions it mains to answer are:

* Which patients with venous thromboembolism should accept long-term anticoagulation therapy?
* Mechanism and prognosis of venous thromboembolism. Participants will receive yearly follow-ups through telephone, hospitalization, or outpatient care.

Detailed description: Venous thromboembolism (VTE), including deep venous thrombosis and pulmonary embolism, is a class of diseases with strong occultation, high mortality, and a high recurrence rate.Long-term anticoagulant therapy can reduce the risk of recurrence. Although long-term anticoagulation can reduce the risk of VTE recurrence, it will also increase the risk of major bleeding and the economic burden of long-term anticoagulation. Therefore, stratifying the risk of VTE recurrence and preventing recurrence with accurate anticoagulant therapy is an urgent problem in VTE management.

Investigators will establish a prospective nationwide cohort of VTE, develop a unified follow-up plan, and conduct whole-life follow-up management for patients. Demographic, clinical, imaging, laboratory indicators, gene, and other information of patients will be collected. A VTE patient database with complete clinical phenotype data, genetic data, and biological samples will be established.

Investigators will construct a VTE recurrence risk prediction model based on Chinese data to provide clinical decision suggestions for clinicians to select appropriate individualized anticoagulant duration according to risk stratification. VTE patients with low recurrence risk could avoid long-term anticoagulant therapy.

Eligibility criteria: Inclusion Criteria:

* Age greater or equal to 18.
* Patients diagnosed with venous thromboembolism.

Exclusion Criteria:

* Pregnant or lactating women
* Patients with active tumor

Primary outcomes:
measure: Recurrence
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Bleeding episode
timeFrame: through study completion, an average of 1 year
measure: All-cause death
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese Academy of Medical Sciences Fuwai Hospital
state: Beijing
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Lu Hua
role: PRINCIPAL_INVESTIGATOR
References:
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