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The Swiss Venous Thromboembolism Cohort 65+ (SWITCO65+)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00973596
Recruitment Status : Completed
First Posted : September 9, 2009
Last Update Posted : December 2, 2014
Sponsor:
Information provided by (Responsible Party):
Drahomir Aujesky, University of Bern

Tracking Information
First Submitted Date September 8, 2009
First Posted Date September 9, 2009
Last Update Posted Date December 2, 2014
Study Start Date September 2009
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 8, 2009)
Venous thromboembolism recurrence [ Time Frame: 3-48 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 8, 2009)
  • Overall mortality [ Time Frame: 3-48 months ]
  • Major bleeding [ Time Frame: 3-48 months ]
  • Post-thrombotic syndrome [ Time Frame: 3-48 months ]
  • Generic and disease-specific health-related quality of life [ Time Frame: 3-48 months ]
  • Medical resource utilization [ Time Frame: 3-48 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Swiss Venous Thromboembolism Cohort 65+
Official Title 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 Observational
Study Design 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 Venous Thromboembolism
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 14, 2012)
1003
Original Estimated Enrollment
 (submitted: September 8, 2009)
649
Actual Study Completion Date December 2013
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 65 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT00973596
Other Study ID Numbers 33CSCO-122 659/139 470
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Drahomir Aujesky, University of Bern
Study Sponsor University of Lausanne Hospitals
Collaborators Not Provided
Investigators Not Provided
PRS Account University of Lausanne Hospitals
Verification Date December 2014