Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00535171




Registration number
NCT00535171
Ethics application status
Date submitted
25/09/2007
Date registered
26/09/2007
Date last updated
22/01/2010

Titles & IDs
Public title
Venous Thromboembolism Taskforce Audit Program
Scientific title
Venous Thromboembolism Taskforce Audit Program
Secondary ID [1] 0 0
DIREG_L_01927
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Thrombosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
- Hospital admission for an acute illness with an in-patient hospital stay of 3 days or
more.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
8764
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sanofi-Aventis - MacQuarie Park
Recruitment postcode(s) [1] 0 0
- MacQuarie Park

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00535171
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Fiona Howard
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00535171