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Venous ThromboembolismSWITCO65+NCT00973596

The Swiss Venous Thromboembolism Cohort 65+

An observational study of Venous Thromboembolism, run by University of Lausanne Hospitals at 9 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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) Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Venous Thromboembolism
How many people
1,003 participants
Where
9 sitesSwitzerland
Study dates
Sep 2009to Dec 2013
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

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

Who may be able to join

  • Objectively confirmed acute pulmonary embolism and/or deep vein thrombosis
  • Age >=65 years

Who cannot join

  • 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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Switzerland9 sites

  • Kantonsspital Baden

    Baden

  • University Hospital of Basel

    Basel

  • University Hospital of Bern

    Bern

  • Kantonsspital Frauenfeld

    Frauenfeld

  • University Hospital of Geneva

    Geneva

  • University Hospital of Lausanne

    Lausanne

  • Kantonsspital Luzern

    Lucerne

  • Kantonsspital St. Gallen

    Sankt Gallen

  • University Hospital of Zurich

    Zurich

Other trials in Switzerland

About this study

Official title: 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)

Medical subject headings
Venous Thromboembolism

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Venous thromboembolism recurrence

    Measured: 3-48 months

Secondary outcomes (5)

  1. Overall mortality

    Measured: 3-48 months

  2. Major bleeding

    Measured: 3-48 months

  3. Post-thrombotic syndrome

    Measured: 3-48 months

  4. Generic and disease-specific health-related quality of life

    Measured: 3-48 months

  5. Medical resource utilization

    Measured: 3-48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionMar 2012
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,003 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00973596
Sponsor's protocol ID
33CSCO-122 659/139 470
Acronym
SWITCO65+
Status last verified
Dec 2014
First submitted
8 Sep 2009
Last updated
2 Dec 2014
Results posted
No
Data monitoring committee
No

Publications

  • Jaquet E, Tritschler T, Stalder O, Limacher A, Mean M, Rodondi N, Aujesky D. Prediction of short-term prognosis in elderly patients with acute pulmonary embolism: validation of the RIETE score. J Thromb Haemost. 2018 Jul;16(7):1313-1320. doi: 10.1111/jth.14137. Epub 2018 May 30.

    PubMed 29733493

  • Lauber S, Limacher A, Tritschler T, Stalder O, Mean M, Righini M, Aschwanden M, Beer JH, Frauchiger B, Osterwalder J, Kucher N, Lammle B, Cornuz J, Angelillo-Scherrer A, Matter CM, Husmann M, Banyai M, Staub D, Mazzolai L, Hugli O, Rodondi N, Aujesky D. Predictors and Outcomes of Recurrent Venous Thromboembolism in Elderly Patients. Am J Med. 2018 Jun;131(6):703.e7-703.e16. doi: 10.1016/j.amjmed.2017.12.015. Epub 2018 Jan 4.

    PubMed 29307536

  • Seiler E, Limacher A, Mean M, Beer HJ, Osterwalder J, Frauchiger B, Righini M, Aschwanden M, Matter CM, Banyai M, Kucher N, Staub D, Lammle B, Rodondi N, Squizzato A, Aujesky D. Derivation and validation of a novel bleeding risk score for elderly patients with venous thromboembolism on extended anticoagulation. Thromb Haemost. 2017 Aug 24;117(10). doi: 10.1160/TH17-03-0162. Online ahead of print.

    PubMed 28837210

  • Hofmann E, Limacher A, Mean M, Kucher N, Righini M, Frauchiger B, Beer JH, Osterwalder J, Aschwanden M, Matter CM, Banyai M, Egloff M, Hugli O, Staub D, Bounameaux H, Rodondi N, Aujesky D. Echocardiography does not predict mortality in hemodynamically stable elderly patients with acute pulmonary embolism. Thromb Res. 2016 Sep;145:67-71. doi: 10.1016/j.thromres.2016.07.014. Epub 2016 Jul 27.

    PubMed 27498122

  • Vuilleumier N, Simona A, Mean M, Limacher A, Lescuyer P, Gerstel E, Bounameaux H, Aujesky D, Righini M. Comparison of Cardiac and Non-Cardiac Biomarkers for Risk Stratification in Elderly Patients with Non-Massive Pulmonary Embolism. PLoS One. 2016 May 24;11(5):e0155973. doi: 10.1371/journal.pone.0155973. eCollection 2016.

    PubMed 27219621

  • Tritschler T, Mean M, Limacher A, Rodondi N, Aujesky D. Predicting recurrence after unprovoked venous thromboembolism: prospective validation of the updated Vienna Prediction Model. Blood. 2015 Oct 15;126(16):1949-51. doi: 10.1182/blood-2015-04-641225. Epub 2015 Sep 4.

    PubMed 26341256

  • Frey PM, Mean M, Limacher A, Jaeger K, Beer HJ, Frauchiger B, Aschwanden M, Rodondi N, Righini M, Egloff M, Osterwalder J, Kucher N, Angelillo-Scherrer A, Husmann M, Banyai M, Matter CM, Aujesky D. Physical activity and risk of bleeding in elderly patients taking anticoagulants. J Thromb Haemost. 2015 Feb;13(2):197-205. doi: 10.1111/jth.12793. Epub 2014 Dec 30.

    PubMed 25403550

Questions about this trial

What is this clinical trial studying?

An observational study of Venous Thromboembolism, run by University of Lausanne Hospitals at 9 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Venous thromboembolism recurrence (time frame: 3-48 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00973596, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2014.

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