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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

January 14, 2011
May 15, 2012
December 2010
November 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01277536 on ClinicalTrials.gov Archive Site
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Explicit Assessment of Thromboembolic Risk and Prophylaxis for Medical Patients in Switzerland
Explicit Assessment of Thromboembolic Risk and Prophylaxis for Medical Patients in Switzerland (ESTIMATE): Evaluation of a Prediction Rule

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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Several public hospitals of Switzerland, genral internal medicine divisions
Venous Thromboembolism
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hospitalization >24 hours
Chopard P, Spirk D, Bounameaux H. Identifying acutely ill medical patients requiring thromboprophylaxis. J Thromb Haemost. 2006 Apr;4(4):915-6. No abstract available.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1478
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01277536
ESTIMATE
No
Mathieu R NENDAZ, University Hospital, Geneva
University Hospital, Geneva
  • University Hospital Inselspital, Berne
  • Kantonsspital Baden
  • University of Zurich
  • Luzerner Kantonsspital
  • Cantonal Hospital of St. Gallen
  • Sanofi
Principal Investigator: Mathieu R Nendaz, Dr General Internal Medicine Division, University Hospitals of Geneva
University Hospital, Geneva
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP