NCT00535171

Brief Summary

To determine the effect of an interventional campaign run by a dedicated "VTE Nurse Educator" over a 6-month period and the effect on prophylaxis rates. To determine the proportion of medically admitted patients with risk factors for VTE. To assess and compare the use of venous thromboembolism (VTE) prophylaxis in hospitalized medical patients versus recommendations and current guidelines. To determine the patient characteristics of those deemed to be at risk of VTE. To determine the proportion of patients receiving appropriate thromboprophylaxis for their risk. To determine the type and duration (where possible) of prophylaxis used.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
8,764

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

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

June 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Last Updated

January 22, 2010

Status Verified

January 1, 2010

Enrollment Period

1.2 years

First QC Date

September 25, 2007

Last Update Submit

January 21, 2010

Conditions

Venous Thrombosis

Eligibility Criteria

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

Venous thromboembolism in medical patients bedridden due to acute illness.

You may qualify if:

  • Hospital admission for an acute illness with an in-patient hospital stay of 3 days or more.

You may not qualify if:

  • Patients who have undergone any type of surgery during current admission
  • Patients who are admitted to a ward or department that is excluded from this study e.g psychiatric, paediatric, maternity, intensive care unit, coronary care unit.
  • Prior enrollment in this protocol during current admission
  • Prior enrollment in a VTE study involving pharmaceutical or mechanical treatment within last 90 days.
  • Admission for suspected or diagnosed deep vein thrombosis
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis

Macquarie Park, Australia

Location

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Fiona Howard

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 25, 2007

First Posted

September 26, 2007

Study Start

June 1, 2007

Primary Completion

August 1, 2008

Last Updated

January 22, 2010

Record last verified: 2010-01

Locations

AU(1)