Long-term Surveillance of Patients With Venous Thromboembolism: a Nationwide Prospective Cohort Study

NCT ID: NCT06073366

Last Updated: 2023-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-01

Study Completion Date

2025-04-30

Brief Summary

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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

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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.

Conditions

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Venous Thromboembolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Pregnant or lactating women
* Patients with active tumor
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

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Lu Hua

Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lu Hua

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences, Fuwai Hospital

Locations

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Chinese Academy of Medical Sciences Fuwai Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Tingting Guo

Role: CONTACT

+86 18610094559

Facility Contacts

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Tingting Guo, M.D

Role: primary

+86 18610094559

References

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Khan F, Rahman A, Carrier M, Kearon C, Weitz JI, Schulman S, Couturaud F, Eichinger S, Kyrle PA, Becattini C, Agnelli G, Brighton TA, Lensing AWA, Prins MH, Sabri E, Hutton B, Pinede L, Cushman M, Palareti G, Wells GA, Prandoni P, Buller HR, Rodger MA; MARVELOUS Collaborators. Long term risk of symptomatic recurrent venous thromboembolism after discontinuation of anticoagulant treatment for first unprovoked venous thromboembolism event: systematic review and meta-analysis. BMJ. 2019 Jul 24;366:l4363. doi: 10.1136/bmj.l4363.

Reference Type BACKGROUND
PMID: 31340984 (View on PubMed)

Rodger MA, Kahn SR, Wells PS, Anderson DA, Chagnon I, Le Gal G, Solymoss S, Crowther M, Perrier A, White R, Vickars L, Ramsay T, Betancourt MT, Kovacs MJ. Identifying unprovoked thromboembolism patients at low risk for recurrence who can discontinue anticoagulant therapy. CMAJ. 2008 Aug 26;179(5):417-26. doi: 10.1503/cmaj.080493.

Reference Type BACKGROUND
PMID: 18725614 (View on PubMed)

Eichinger S, Heinze G, Jandeck LM, Kyrle PA. Risk assessment of recurrence in patients with unprovoked deep vein thrombosis or pulmonary embolism: the Vienna prediction model. Circulation. 2010 Apr 13;121(14):1630-6. doi: 10.1161/CIRCULATIONAHA.109.925214. Epub 2010 Mar 29.

Reference Type BACKGROUND
PMID: 20351233 (View on PubMed)

Tosetto A, Iorio A, Marcucci M, Baglin T, Cushman M, Eichinger S, Palareti G, Poli D, Tait RC, Douketis J. Predicting disease recurrence in patients with previous unprovoked venous thromboembolism: a proposed prediction score (DASH). J Thromb Haemost. 2012 Jun;10(6):1019-25. doi: 10.1111/j.1538-7836.2012.04735.x.

Reference Type BACKGROUND
PMID: 22489957 (View on PubMed)

Franco Moreno AI, Garcia Navarro MJ, Ortiz Sanchez J, Martin Diaz RM, Madronal Cerezo E, de Ancos Aracil CL, Cabello Clotet N, Perales Fraile I, Gimeno Garcia S, Montero Hernandez C, Zapatero Gaviria A, Ruiz Giardin JM. A risk score for prediction of recurrence in patients with unprovoked venous thromboembolism (DAMOVES). Eur J Intern Med. 2016 Apr;29:59-64. doi: 10.1016/j.ejim.2015.12.010. Epub 2016 Jan 8.

Reference Type BACKGROUND
PMID: 26775136 (View on PubMed)

Le Gal G, Kovacs MJ, Bertoletti L, Couturaud F, Dennie C, Hirsch AM, Huisman MV, Klok FA, Kraaijpoel N, Mallick R, Pecarskie A, Pena E, Phillips P, Pichon I, Ramsay T, Righini M, Rodger MA, Roy PM, Sanchez O, Schmidt J, Schulman S, Shivakumar S, Trinh-Duc A, Verdet R, Vinsonneau U, Wells P, Wu C, Yeo E, Carrier M; SSPE Investigators. Risk for Recurrent Venous Thromboembolism in Patients With Subsegmental Pulmonary Embolism Managed Without Anticoagulation : A Multicenter Prospective Cohort Study. Ann Intern Med. 2022 Jan;175(1):29-35. doi: 10.7326/M21-2981. Epub 2021 Nov 23.

Reference Type BACKGROUND
PMID: 34807722 (View on PubMed)

Other Identifiers

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2022-I2M-C&T-B-040

Identifier Type: -

Identifier Source: org_study_id

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