The Swiss Venous Thromboembolism Cohort 65+

Venous Thromboembolism Clinical Trial

— SWITCO65+  

Official title:

Swiss Venous Thromboembolism Cohort Study of Elderly Patients With Acute Venous Thromboembolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00973596
• Other study ID #: 33CSCO-122 659/139 470
• Status: Completed
• Phase: N/A
• First received: September 8, 2009
• Last updated: December 1, 2014
• Start date: September 2009
• Est. completion date: December 2013

Study information

• Verified date: December 2014
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial Summary

The purpose of this prospective multicenter cohort study is to examine long-term medical outcomes, quality of life, and medical resource utilization in elderly patients (>= 65 years) with acute venous thromboembolism (i.e., acute pulmonary embolism and/or deep vein thrombosis)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1003
• Est. completion date: December 2013
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Objectively confirmed acute pulmonary embolism and/or deep vein thrombosis

• Age >=65 years

Exclusion Criteria:

• Thrombosis at a different site than lower limb

• Catheter-related thrombosis

• Insufficient spoken language ability in German or French

• Follow-up not possible (e.g., terminally ill patients)

• Informed consent not possible (e.g., severe dementia)

• Prior enrolment in the study

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Locations

Country	Name	City	State
Switzerland	Kantonsspital Baden	Baden
Switzerland	University Hospital of Basel	Basel
Switzerland	University Hospital of Bern	Bern
Switzerland	Kantonsspital Frauenfeld	Frauenfeld
Switzerland	University Hospital of Geneva	Geneva
Switzerland	University Hospital of Lausanne	Lausanne
Switzerland	Kantonsspital Luzern	Luzern
Switzerland	Kantonsspital St. Gallen	St. Gallen
Switzerland	University Hospital of Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Venous thromboembolism recurrence		3-48 months	Yes
Secondary	Overall mortality		3-48 months	Yes
Secondary	Major bleeding		3-48 months	Yes
Secondary	Post-thrombotic syndrome		3-48 months	No
Secondary	Generic and disease-specific health-related quality of life		3-48 months	No
Secondary	Medical resource utilization		3-48 months	No