Clinical trial NCT00973596: The Swiss Venous Thromboembolism Cohort 65+
Official title: Swiss Venous Thromboembolism Cohort Study of Elderly Patients With Acute Venous Thromboembolism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2009-09-09
Enrollment: 1003
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients and inpatients with acute venous thromboembolism from 9 Swiss university and non-university hospitals

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)


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

Primary outcomes:
measure: Venous thromboembolism recurrence
timeFrame: 3-48 months
Secondary outcomes:
measure: Overall mortality
timeFrame: 3-48 months
measure: Major bleeding
timeFrame: 3-48 months
measure: Post-thrombotic syndrome
timeFrame: 3-48 months
measure: Generic and disease-specific health-related quality of life
timeFrame: 3-48 months
measure: Medical resource utilization
timeFrame: 3-48 months
Other outcomes:
Locations:
city: Baden
country: Switzerland
facility: Kantonsspital Baden
city: Basel
country: Switzerland
facility: University Hospital of Basel
city: Bern
country: Switzerland
facility: University Hospital of Bern
city: Frauenfeld
country: Switzerland
facility: Kantonsspital Frauenfeld
city: Geneva
country: Switzerland
facility: University Hospital of Geneva
city: Lausanne
country: Switzerland
facility: University Hospital of Lausanne
city: Luzern
country: Switzerland
facility: Kantonsspital Luzern
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
city: Zurich
country: Switzerland
facility: University Hospital of Zurich
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.