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.

Study Overview

• Status: Completed
• Conditions: Venous Thromboembolism

• Study Type: Observational
• Enrollment (Actual): 1478

Contacts and Locations

Study Locations

• Switzerland
  • Baden, Switzerland
    • Kantonsspital
  • Bern, Switzerland
    • University Hospitals
  • Fribourg, Switzerland
    • Cantonal Hospital
  • Geneva, Switzerland
    • University Hospitals
  • Lüzern, Switzerland
    • Kantonsspital
  • St. Gallen, Switzerland
    • Cantonal Hospital
  • Zürich, Switzerland
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Several public hospitals of Switzerland, genral internal medicine divisions

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
hospitalization >24 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Collaborators: Sanofi; University of Zurich; University Hospital Inselspital, Berne; Luzerner Kantonsspital; Cantonal Hospital of St. Gallen; Kantonsspital Baden
• Investigators: Principal Investigator: Mathieu R Nendaz, Dr, General Internal Medicine Division, University Hospitals of Geneva

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: January 14, 2011
• First Submitted That Met QC Criteria: January 14, 2011
• First Posted (Estimate): January 17, 2011

Study Record Updates

• Last Update Posted (Estimate): March 18, 2014
• Last Update Submitted That Met QC Criteria: March 17, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism; Venous Thromboembolism
• Other Study ID Numbers: ESTIMATE