The Swiss Venous Thromboembolism Cohort 65+ (SWITCO65+)

December 1, 2014 updated by: Drahomir Aujesky, University of Lausanne Hospitals

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

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)

Study Overview

Status

Completed

Conditions

Venous Thromboembolism

Study Type

Observational

Enrollment (Actual)

1003

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Switzerland
- - Baden, Switzerland
    - Kantonsspital Baden
  - Basel, Switzerland
    - University Hospital of Basel
  - Bern, Switzerland
    - University Hospital of Bern
  - Frauenfeld, Switzerland
    - Kantonsspital Frauenfeld
  - Geneva, Switzerland
    - University Hospital of Geneva
  - Lausanne, Switzerland
    - University Hospital of Lausanne
  - Luzern, Switzerland
    - Kantonsspital Luzern
  - St. Gallen, Switzerland
    - Kantonsspital St. Gallen
  - Zurich, Switzerland
    - University Hospital of Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Outpatients and inpatients with acute venous thromboembolism from 9 Swiss university and non-university hospitals

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Venous thromboembolism recurrence Time Frame: 3-48 months	3-48 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall mortality Time Frame: 3-48 months	3-48 months
Major bleeding Time Frame: 3-48 months	3-48 months
Post-thrombotic syndrome Time Frame: 3-48 months	3-48 months
Generic and disease-specific health-related quality of life Time Frame: 3-48 months	3-48 months
Medical resource utilization Time Frame: 3-48 months	3-48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lausanne Hospitals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

September 8, 2009

First Submitted That Met QC Criteria