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Explicit Assessment of Thromboembolic Risk and Prophylaxis for Medical Patients in Switzerland

This study has been completed.
Sponsor:
Collaborators:
University Hospital Inselspital, Berne
Kantonsspital Baden
University of Zurich
Luzerner Kantonsspital
Cantonal Hospital of St. Gallen
Sanofi
Information provided by (Responsible Party):
Mathieu R NENDAZ, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01277536
First received: January 14, 2011
Last updated: May 15, 2012
Last verified: May 2012
History of Changes
  Purpose

Until now, no risk assessment model informing about the need of thromboprophylaxis in patients admitted for an acute medical event has been validated.

The goal of this project is to indirectly validate a model developed in Geneva by a non -interventional study involving the collection of patient characteristics during the hospitalization and a 3-month follow-up. These data will allow for the determination of the patient's risk, according to the Geneva model, and its validity, according the actual thrombo-embolic events, corrected for the thromboprophylaxis received.

The project is multicentric in Switzerland (5-10 centers) and should involve about 1000 patients.

First amendment (may 2011) : we have obtained the IRB approval for collecting data from patients who die during their hospital stay and for whom informed consent is not be possible to obtain.


Condition
Venous Thromboembolism

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Explicit Assessment of Thromboembolic Risk and Prophylaxis for Medical Patients in Switzerland (ESTIMATE): Evaluation of a Prediction Rule

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • relationship between the combined rate of fatal and non-fatal symptomatic venous thromboembolism and bleeding events and the calculated risk score at 90 days after hospital admission [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    evaluation of the relationship between the combined rate of fatal and non-fatal symptomatic venous thromboembolism and bleeding events at 90 days after hospital admission on one hand, and the calculated risk score provided by the Geneva Risk Assessment Models (RAM) at hospital admission on the other hand


Enrollment: 1478
Study Start Date: December 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
hospitalization >24 hours

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Several public hospitals of Switzerland, genral internal medicine divisions

Criteria

Inclusion Criteria:

  • Patients admitted (minimal stay >24 hours) to medical hospital wards
  • Age ≥18 years
  • Ability to give an informed consent, as informed by the physicians in charge of the patient

Exclusion Criteria:

  • Patients admitted to non-medical hospital wards
  • Patients with therapeutic anticoagulation at hospital admission
  • Patients admitted for a disease requiring therapeutic anticoagulation (MTE or other)
  • Patients unable to give an informed consent, as informed by the physicians in charge of the patient
  • Patients without signed informed consent
  • Patients already included in this study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01277536

Locations
Switzerland
Kantonsspital
Baden, Switzerland
University Hospitals
Bern, Switzerland
Cantonal Hospital
Fribourg, Switzerland
University Hospitals
Geneva, Switzerland
Kantonsspital
Lüzern, Switzerland
Cantonal Hospital
St. Gallen, Switzerland
University Hospital
Zürich, Switzerland
Sponsors and Collaborators
University Hospital, Geneva
University Hospital Inselspital, Berne
Kantonsspital Baden
University of Zurich
Luzerner Kantonsspital
Cantonal Hospital of St. Gallen
Sanofi
Investigators
Principal Investigator: Mathieu R Nendaz, Dr General Internal Medicine Division, University Hospitals of Geneva
  More Information

Publications:

Responsible Party: Mathieu R NENDAZ, MD, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01277536     History of Changes
Other Study ID Numbers: ESTIMATE
Study First Received: January 14, 2011
Last Updated: May 15, 2012
Health Authority: Switzerland: Laws and standards

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
 Vascular Diseases
Cardiovascular Diseases
Thrombosis

ClinicalTrials.gov processed this record on May 23, 2013