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

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.

Completed

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Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kantonsspital, Baden, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Collaborators

Cantonal Hospital of St. Gallen
Insel Gruppe AG, University Hospital Bern
Kantonsspital Baden
Luzerner Kantonsspital
Sanofi
University of Zurich

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Jan 17, 2011
Registry last updated: Mar 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed