Explicit Assessment of Thromboembolic Risk and Prophylaxis for Medical Patients in Switzerland
NCT ID: NCT01277536
Last Updated: 2014-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1478 participants
OBSERVATIONAL
2010-12-31
2011-11-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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hospitalization >24 hours
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Age ≥18 years
* Ability to give an informed consent, as informed by the physicians in charge of the patient
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Insel Gruppe AG, University Hospital Bern
OTHER
Kantonsspital Baden
OTHER
University of Zurich
OTHER
Luzerner Kantonsspital
OTHER
Cantonal Hospital of St. Gallen
OTHER
Sanofi
INDUSTRY
University Hospital, Geneva
OTHER
Responsible Party
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Mathieu R NENDAZ
MD
Principal Investigators
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Mathieu R Nendaz, Dr
Role: PRINCIPAL_INVESTIGATOR
General Internal Medicine Division, University Hospitals of Geneva
Locations
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Kantonsspital
Baden, , Switzerland
University Hospitals
Bern, , Switzerland
Cantonal Hospital
Fribourg, , Switzerland
University Hospitals
Geneva, , Switzerland
Kantonsspital
Lüzern, , Switzerland
Cantonal Hospital
Sankt Gallen, , Switzerland
University Hospital
Zurich, , Switzerland
Countries
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References
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Chopard P, Spirk D, Bounameaux H. Identifying acutely ill medical patients requiring thromboprophylaxis. J Thromb Haemost. 2006 Apr;4(4):915-6. doi: 10.1111/j.1538-7836.2006.01818.x. No abstract available.
Nendaz M, Spirk D, Kucher N, Aujesky D, Hayoz D, Beer JH, Husmann M, Frauchiger B, Korte W, Wuillemin WA, Jager K, Righini M, Bounameaux H. Multicentre validation of the Geneva Risk Score for hospitalised medical patients at risk of venous thromboembolism. Explicit ASsessment of Thromboembolic RIsk and Prophylaxis for Medical PATients in SwitzErland (ESTIMATE). Thromb Haemost. 2014 Mar 3;111(3):531-8. doi: 10.1160/TH13-05-0427. Epub 2013 Nov 14.
Spirk D, Nendaz M, Aujesky D, Hayoz D, Beer JH, Husmann M, Frauchiger B, Korte W, Wuillemin WA, Righini M, Bounameaux H, Kucher N. Predictors of thromboprophylaxis in hospitalised medical patients. Explicit ASsessment of Thromboembolic RIsk and Prophylaxis for Medical PATients in SwitzErland (ESTIMATE). Thromb Haemost. 2015 May;113(5):1127-34. doi: 10.1160/TH14-06-0525. Epub 2015 Jan 22.
Other Identifiers
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ESTIMATE
Identifier Type: -
Identifier Source: org_study_id
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