Clinical trial NCT01277536: Explicit Assessment of Thromboembolic Risk and Prophylaxis for Medical Patients in Switzerland
Official title: Explicit Assessment of Thromboembolic Risk and Prophylaxis for Medical Patients in Switzerland (ESTIMATE): Evaluation of a Prediction Rule
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: Insel Gruppe AG, University Hospital Bern
name: Kantonsspital Baden
name: University of Zurich
name: Luzerner Kantonsspital
name: Cantonal Hospital of St. Gallen
name: Sanofi
First posted: 2011-01-17
Enrollment: 1478
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Several public hospitals of Switzerland, genral internal medicine divisions

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Baden
country: Switzerland
facility: Kantonsspital
city: Bern
country: Switzerland
facility: University Hospitals
city: Fribourg
country: Switzerland
facility: Cantonal Hospital
city: Geneva
country: Switzerland
facility: University Hospitals
city: Lüzern
country: Switzerland
facility: Kantonsspital
city: St. Gallen
country: Switzerland
facility: Cantonal Hospital
city: Zürich
country: Switzerland
facility: University Hospital
Study officials:
affiliation: General Internal Medicine Division, University Hospitals of Geneva
name: Mathieu R Nendaz, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.