Venous Thromboembolism Clinical Trial
Official title:
Explicit Assessment of Thromboembolic Risk and Prophylaxis for Medical Patients in Switzerland (ESTIMATE): Evaluation of a Prediction Rule
Verified date | March 2014 |
Source | University Hospital, Geneva |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Laws and standards |
Study type | Observational |
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.
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 |
Observational Model: Cohort, Time Perspective: Prospective
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 |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Geneva | Cantonal Hospital of St. Gallen, Kantonsspital Baden, Luzerner Kantonsspital, Sanofi, University Hospital Inselspital, Berne, University of Zurich |
Switzerland,
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
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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