The Swiss Venous Thromboembolism Cohort 65+ (SWITCO65+)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Drahomir Aujesky, University of Bern

ClinicalTrials.gov Identifier:

NCT00973596

First received: September 8, 2009

Last updated: April 14, 2012

Last verified: April 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	September 8, 2009
Last Updated Date	April 14, 2012
Start Date ^ICMJE	September 2009
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: September 8, 2009)	Venous thromboembolism recurrence [ Time Frame: 3-48 months ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00973596 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 8, 2009)	Overall mortality [ Time Frame: 3-48 months ] [ Designated as safety issue: Yes ] Major bleeding [ Time Frame: 3-48 months ] [ Designated as safety issue: Yes ] Post-thrombotic syndrome [ Time Frame: 3-48 months ] [ Designated as safety issue: No ] Generic and disease-specific health-related quality of life [ Time Frame: 3-48 months ] [ Designated as safety issue: No ] Medical resource utilization [ Time Frame: 3-48 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Swiss Venous Thromboembolism Cohort 65+
Official Title ^ICMJE	Swiss Venous Thromboembolism Cohort Study of Elderly Patients With Acute Venous Thromboembolism
Brief 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)
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Outpatients and inpatients with acute venous thromboembolism from 9 Swiss university and non-university hospitals
Condition ^ICMJE	Venous Thromboembolism
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	1003
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	65 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Switzerland

Administrative Information
NCT Number ^ICMJE	NCT00973596
Other Study ID Numbers ^ICMJE	33CSCO-122 659/139 470
Has Data Monitoring Committee	No
Responsible Party	Drahomir Aujesky, University of Bern
Study Sponsor ^ICMJE	University of Lausanne Hospitals
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Lausanne Hospitals
Verification Date	April 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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