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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01277536
Other study ID # ESTIMATE
Secondary ID
Status Completed
Phase N/A
First received January 14, 2011
Last updated March 17, 2014
Start date December 2010
Est. completion date November 2011

Study information

Verified date March 2014
Source University Hospital, Geneva
Contact n/a
Is FDA regulated No
Health authority Switzerland: Laws and standards
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 1478
Est. completion date November 2011
Est. primary completion date November 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
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

Sponsors (7)

Lead Sponsor Collaborator
University Hospital, Geneva Cantonal Hospital of St. Gallen, Kantonsspital Baden, Luzerner Kantonsspital, Sanofi, University Hospital Inselspital, Berne, University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

Chopard P, Spirk D, Bounameaux H. Identifying acutely ill medical patients requiring thromboprophylaxis. J Thromb Haemost. 2006 Apr;4(4):915-6. — View Citation

Nendaz M, Spirk D, Kucher N, Aujesky D, Hayoz D, Beer JH, Husmann M, Frauchiger B, Korte W, Wuillemin WA, Jäger K, Righini M, Bounameaux H. Multicentre validation of the Geneva Risk Score for hospitalised medical patients at risk of venous thromboembolism — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 90 days No
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