NCT00973596

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,003

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2009

Longer than P75 for all trials

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 2, 2014

Status Verified

December 1, 2014

Enrollment Period

2.5 years

First QC Date

September 8, 2009

Last Update Submit

December 1, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Venous thromboembolism recurrence

    3-48 months

Secondary Outcomes (5)

  • Overall mortality

    3-48 months

  • Major bleeding

    3-48 months

  • Post-thrombotic syndrome

    3-48 months

  • Generic and disease-specific health-related quality of life

    3-48 months

  • Medical resource utilization

    3-48 months

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Kantonsspital Baden

Baden, Switzerland

Location

University Hospital of Basel

Basel, Switzerland

Location

University Hospital of Bern

Bern, Switzerland

Location

Kantonsspital Frauenfeld

Frauenfeld, Switzerland

Location

University Hospital of Geneva

Geneva, Switzerland

Location

University Hospital of Lausanne

Lausanne, Switzerland

Location

Kantonsspital Luzern

Lucerne, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, Switzerland

Location

University Hospital of Zurich

Zurich, Switzerland

Location

Related Publications (7)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Division of General Internal Medicine

Study Record Dates

First Submitted

September 8, 2009

First Posted

September 9, 2009

Study Start

September 1, 2009

Primary Completion

March 1, 2012

Study Completion

December 1, 2013

Last Updated

December 2, 2014

Record last verified: 2014-12

Locations