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

Completed

• Conditions: Venous Thromboembolism

• Registration Number: NCT01277536
• Lead Sponsor: University Hospital, Geneva

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-01-14
• Study First Submitted QC: 2011-01-14
• Study First Posted: 2011-01-17
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-17
• Last Update Posted: 2014-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1478

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	90 days	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

Trial Locations

Locations (4)

Kantonsspital; 🇨🇭 Lüzern, Switzerland

University Hospitals; 🇨🇭 Geneva, Switzerland

Cantonal Hospital; 🇨🇭 St. Gallen, Switzerland

University Hospital; 🇨🇭 Zürich, Switzerland