NCT01277536

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,478

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2010

Shorter than P25 for all trials

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 14, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 17, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

March 18, 2014

Status Verified

March 1, 2014

Enrollment Period

11 months

First QC Date

January 14, 2011

Last Update Submit

March 17, 2014

Conditions

Venous Thromboembolism

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

hospitalization >24 hours

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Several public hospitals of Switzerland, genral internal medicine divisions

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Kantonsspital

Baden, Switzerland

Location

University Hospitals

Bern, Switzerland

Location

Cantonal Hospital

Fribourg, Switzerland

Location

University Hospitals

Geneva, Switzerland

Location

Kantonsspital

Lüzern, Switzerland

Location

Cantonal Hospital

Sankt Gallen, Switzerland

Location

University Hospital

Zurich, Switzerland

Location

Related Publications (3)

  • 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.

    PMID: 16634771BACKGROUND

  • 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.

    PMID: 24226257RESULT

  • 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.

    PMID: 25608607DERIVED

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Mathieu R Nendaz, Dr

    General Internal Medicine Division, University Hospitals of Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 14, 2011

First Posted

January 17, 2011

Study Start

December 1, 2010

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

March 18, 2014

Record last verified: 2014-03

Locations

CH(7)