Explicit Assessment of Thromboembolic Risk and Prophylaxis for Medical Patients in Switzerland
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01277536|
Recruitment Status : Completed
First Posted : January 17, 2011
Last Update Posted : March 18, 2014
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||1478 participants|
|Official Title:||Explicit Assessment of Thromboembolic Risk and Prophylaxis for Medical Patients in Switzerland (ESTIMATE): Evaluation of a Prediction Rule|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||November 2011|
|hospitalization >24 hours|
- 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 [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01277536
|St. Gallen, Switzerland|
|Principal Investigator:||Mathieu R Nendaz, Dr||General Internal Medicine Division, University Hospitals of Geneva|