Venous ThrombosisNCT00535171
Venous Thromboembolism Taskforce Audit Program
An observational study of Venous Thrombosis, run by Sanofi at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thrombosis
- How many people
- 8,764 participants
- Where
- 1 siteAustralia
- Study dates
- Jun 2007to Aug 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Venous thromboembolism in medical patients bedridden due to acute illness.
Who may be able to join
- Hospital admission for an acute illness with an in-patient hospital stay of 3 days or more.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Venous Thrombosis
- Medical subject headings
- Venous Thrombosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startJun 2007
- Primary completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThrombosisStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 8,764 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Fiona Howard, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00535171
- Sponsor's protocol ID
- DIREG_L_01927
- Status last verified
- Jan 2010
- First submitted
- 25 Sep 2007
- Last updated
- 22 Jan 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venous Thromboembolism Taskforce Audit Program
- ClinicalTrials.gov ID
- NCT00535171
- Acronym / sponsor ID
- DIREG_L_01927
- Conditions
- Venous Thrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,764 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Aug 2008 (actual)
- First posted
- 26 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Venous thromboembolism in medical patients bedridden due to acute illness.
Key inclusion criteria (1 listed)
- Hospital admission for an acute illness with an in-patient hospital stay of 3 days or more.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fiona Howard study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thrombosis, run by Sanofi at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2010.