AzTrials
AzTrials

Quality of Health CarePREVENUNCT01212393

Prevention of Venous Thromboembolism Disease in Emergency Departments

An observational study of Quality of Health Care, run by University Hospital, Angers at 23 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The appropriate use of thromboprophylaxis in medical patients admitted to hospital can substantially reduce the overall burden of disease due to venous thromboembolism. However, the use of thromboprophylaxis in medical setting appears to be generally poor leaving at-risk patients unprotected. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Quality of Health Care
What is being tested?
reminders
How many people
20,000 participants
Where
23 sitesFrance
Study dates
Sep 2009to Jun 2013
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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Eligible centers: Emergency departments previously implicated in research on venous thromboembolism. Eligible patients: patients over 40 years old admitted in participating emergency departments for non traumatic reason

Who may be able to join

  • age over 40 years
  • Emergency department admission for non-traumatic reason
  • Hospitalization in medical setting

Who cannot join

  • patients less than 40 years old
  • patients hospitalized in a facility which doesn't participate to the study
  • 3 months follow-up not possible
  • patients refusing that their personal data are used for medical research
  • patients refusing to be reach for the 3 months follow-up

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

France23 sites

  • UH Agen

    Agen

  • H Argenteuil

    Argenteuil, 95107

  • UH Besançon

    Besançon, 25000

  • H Bethune

    Béthune, 62408

  • H Bobigny

    Bobigny

  • UH Ambroise Pare

    Boulogne-Billancourt, 92100

  • UH Brest

    Brest

  • H Chateauroux

    Châteauroux, 36019

  • H Clermont Ferrand

    Clermont-Ferrand

  • H Compiegne

    Compiègne, 60200

  • UH Dijon

    Dijon, 21033

  • UH Grenoble

    Grenoble, 38043

  • UH La Reunion

    La Réunion

  • UH Marseille

    Marseille

  • UH Metz Thionville

    Metz

  • UH Nantes

    Nantes, 44100

  • UH Nimes

    Nîmes

  • UH la pitié salpetriere

    Paris, 75651

  • H Cochin

    Paris

  • UH Bichat

    Paris

  • UH Hotel Dieu

    Paris

  • UH Poitiers

    Poitiers

  • UH Rennes

    Rennes

Other trials in France

About this study

Official title: Prevention of Venous Thromboembolism Disease for Acutelly Ill Medical Patients Admitted to Hospital : Systematic Analysis of Thrombosis Risk Factors and Remember of Prevention Treatment Indications in Emergency Departments.

The appropriate use of thromboprophylaxis in medical patients admitted to hospital can substantially reduce the overall burden of disease due to venous thromboembolism. However, the use of thromboprophylaxis in medical setting appears to be generally poor leaving at-risk patients unprotected.

We aim to analyse the incidence of symptomatic thromboembolic disease following hospitalisation in medical setting and the efficacy of a multicomponent prevention approach in emergency department including systematic evaluation of thrombosis risk factors and remembers of thrombophylaxis indications and modalities for acutely ill medical patients.

Read more

Design: cluster randomized interventional study - Observational study at patient level

Setting: 30 French emergency departments

Patients: Patients over 40 years old admitted in participating emergency departments and hospitalized for acute medical reasons.

Main judgment criteria: the rate of symptomatic thromboembolic events and severe haemorrhage during a formal 3-months follow-up after hospital admission in patients hospitalized at least 48 hours.

Read the detailed description

Method:

At the end of an observational period of a week, centers will be randomized in two groups: intervention or current practice. In the intervention group, centers will be provided with poster and pocket cards and, if possible, with a computer decision support system remembering venous thromboembolism prophylactic treatment. We will propose no change in current practice in the other group.

Primary outcome: the rate of symptomatic venous thromboembolic events and severe haemorrhage during a formal 3-months follow-up after hospital admission in patients hospitalized at least 48 hours.

All possible thromboembolic events, severe haemorrhages and deaths will be analysed by an adjudication committee blinded of group assignation. Sudden death without obvious cause according to the adjudication committee will be considered as possible fatal pulmonary embolism.

Sample size: We calculated sample size on the basis of primary outcome. Assuming the participation of 30 centers (15 in each group), an intracluster correlation of 0.01, a rate of symptomatic thromboembolic events or severe haemorrhage of 5% in the current practice group, we need a sample of 16170 patients (8085 in each group) to detect a 1.5 percentage absolute difference between the 2 groups (3.5% in the intervention group) with a power of 80% and a significance level of 5%.

Considering a rate of patients hospitalized less than 48 hours around 5% and of lost of follow-up around 3%, we anticipated to include 16500 patients for the main analysis and 18000 patients for the overall study.

Secondary outcomes:

  • The appropriateness of thromboprophylaxis in the overall population and according to group assignation:
  • Number of patients needing prevention treatment according to international recommendations and who have an appropriate treatment.
  • Number of patients without indication of thromboprophylaxis and who do not receive a treatment
  • The rate of symptomatic venous thromboembolic events during a formal 3-months follow-up after hospital admission
  • in all included patients
  • in patients hospitalized at least 48 hours.
  • inpatients hospitalized less than 48 hours
  • The rate of thromboembolic events
  • in patients who had an appropriate thromboprophylactic treatment
  • in patients who had an inappropriate thromboprophylactic treatment
  • in patients who had no thromboprophylactic treatment
  • The rate of severe haemorrhage
  • in patients who had an appropriate thromboprophylactic treatment
  • in patients who had an inappropriate thromboprophylactic treatment
  • in patients who had no thromboprophylactic treatment
Being tested
reminders
Keywords
venous thromboembolism disease, emergency, prevention, thromboprophylaxis, medical, hosptitalization, health care risks
Medical subject headings
Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • remindersBehavioural

    In the intervention group, emergency departments will be provided with poster and pocket cards and, if possible, with a computer decision support system remembering venous thromboembolism prophylactic treatment.

Study groups in NCT01212393
Study groupRoleWhat they receive
Intervention groupreminders
Receives: Behavioral: reminders
current practice groupno intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Symptomatic venous thromboembolic events and severe haemorrhage

    the rate of symptomatic venous thromboembolic events and severe haemorrhage during a formal 3-months follow-up after hospital admission in patients hospitalized at least 48 hours.

    All possible thromboembolic events, severe haemorrhages and deaths will be analysed by an adjudication committee blinded of group assignation. Sudden death without obvious cause according to the adjudication committee will be considered as possible fatal pulmonary embolism.

    Measured: 3 months

Secondary outcomes (4)

  1. Rate of symptomatic venous thromboembolic events

    • The rate of symptomatic venous thromboembolic events during a formal 3-months follow-up after hospital admission oin all included patients oin patients hospitalized at least 48 hours. oin patients hospitalized less than 48 hours

    Measured: 3 months

  2. Rate of thromboembolic events

    • The rate of thromboembolic events oin patients who had an appropriate thromboprophylactic treatment oin patients who had an inappropriate thromboprophylactic treatment oin patients who had no thromboprophylactic treatment

    Measured: 3 months

  3. rate of severe haemorrhage

    • The rate of severe haemorrhage oin patients who had an appropriate thromboprophylactic treatment oin patients who had an inappropriate thromboprophylactic treatment oin patients who had no thromboprophylactic treatment

    Measured: 3 months

  4. appropriateness of thromboprophylaxis

    • The appropriateness of thromboprophylaxis in the overall population and according to group assignation: oNumber of patients needing prevention treatment according to international recommendations and who have an appropriate treatment. oNumber of patients without indication of thromboprophylaxis and who do not receive a treatment

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2010 (estimated)
  2. Study startSep 2009
  3. Primary completionMar 2011
  4. Study completionJun 2013

Resources

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
Other
Time perspective
Prospective
Enrolment
20,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01212393
Sponsor's protocol ID
PHRC 2008-02
Acronym
PREVENU
Status last verified
Dec 2016
First submitted
29 Sep 2010
Last updated
6 Apr 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Roy PM, Rachas A, Meyer G, Le Gal G, Durieux P, El Kouri D, Honnart D, Schmidt J, Legall C, Hausfater P, Chretien JM, Mottier D; PREVENU study group. Multifaceted Intervention to Prevent Venous Thromboembolism in Patients Hospitalized for Acute Medical Illness: A Multicenter Cluster-Randomized Trial. PLoS One. 2016 May 26;11(5):e0154832. doi: 10.1371/journal.pone.0154832. eCollection 2016.

    PubMed 27227406

Questions about this trial

What is this clinical trial studying?

An observational study of Quality of Health Care, run by University Hospital, Angers at 23 sites in France.

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 3 inclusion and 5 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 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in France. 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.

What does the primary outcome measure?

Symptomatic venous thromboembolic events and severe haemorrhage (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01212393, which also lists 1 linked publication.

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 6 Apr 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in