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

Venous Thromboembolism Clinical Trial

Official title:

Explicit Assessment of Thromboembolic Risk and Prophylaxis for Medical Patients in Switzerland (ESTIMATE): Evaluation of a Prediction Rule

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01277536
• Other study ID #: ESTIMATE
• 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

• Thromboembolism
• Venous Thromboembolism

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