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

NCT ID: NCT01277536

Last Updated: 2014-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1478 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-11-30

Brief Summary

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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

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Conditions

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Venous Thromboembolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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hospitalization >24 hours

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role collaborator

Kantonsspital Baden

OTHER

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role collaborator

Luzerner Kantonsspital

OTHER

Sponsor Role collaborator

Cantonal Hospital of St. Gallen

OTHER

Sponsor Role collaborator

Sanofi

INDUSTRY

Sponsor Role collaborator

University Hospital, Geneva

OTHER

Sponsor Role lead

Responsible Party

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Mathieu R NENDAZ

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mathieu R Nendaz, Dr

Role: PRINCIPAL_INVESTIGATOR

General Internal Medicine Division, University Hospitals of Geneva

Locations

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Kantonsspital

Baden, , Switzerland

Site Status

University Hospitals

Bern, , Switzerland

Site Status

Cantonal Hospital

Fribourg, , Switzerland

Site Status

University Hospitals

Geneva, , Switzerland

Site Status

Kantonsspital

Lüzern, , Switzerland

Site Status

Cantonal Hospital

Sankt Gallen, , Switzerland

Site Status

University Hospital

Zurich, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 16634771 (View on PubMed)

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.

Reference Type RESULT
PMID: 24226257 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25608607 (View on PubMed)

Other Identifiers

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ESTIMATE

Identifier Type: -

Identifier Source: org_study_id

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