Prevention of Venous Thromboembolism Disease in Emergency Departments (PREVENU)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT01212393
First received: September 29, 2010
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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.

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.


Condition Intervention
Quality of Health Care
Behavioral: reminders

Study Type: Observational
Study Design: Time Perspective: Prospective
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.

Resource links provided by NLM:


Further study details as provided by University Hospital, Angers:

Primary Outcome Measures:
  • Symptomatic venous thromboembolic events and severe haemorrhage [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

    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.



Secondary Outcome Measures:
  • Rate of symptomatic venous thromboembolic events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    - 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

  • Rate of thromboembolic events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    - 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

  • rate of severe haemorrhage [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    - 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

  • appropriateness of thromboprophylaxis [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

    - 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



Biospecimen Retention:   None Retained

observational study at the patient level - cluster randomized study


Enrollment: 20000
Study Start Date: September 2009
Study Completion Date: June 2013
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Intervention group
reminders
Behavioral: reminders
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.
current practice group
no intervention

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
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01212393

Locations
France
UH Agen
Agen, France
H Argenteuil
Argenteuil, France, 95107
UH Besançon
Besançon, France, 25000
H Bethune
Bethune, France, 62408
H Bobigny
Bobigny, France
UH Ambroise Pare
Boulogne Billancourt, France, 92100
UH Brest
Brest, France
H Chateauroux
Chateauroux, France, 36019
H Clermont Ferrand
Clermont Ferrand, France
H Compiegne
Compiegne, France, 60200
UH Dijon
Dijon, France, 21033
UH Grenoble
Grenoble, France, 38043
UH La Reunion
La Reunion, France
UH Marseille
Marseille, France
UH Metz Thionville
Metz, France
UH Nantes
Nantes, France, 44100
UH Nimes
Nimes, France
UH Bichat
Paris, France
UH Hotel Dieu
Paris, France
H Cochin
Paris, France
UH la pitié salpetriere
Paris, France, 75651
UH Poitiers
Poitiers, France
UH Rennes
Rennes, France
Sponsors and Collaborators
University Hospital, Angers
Investigators
Principal Investigator: Pierre-Marie ROY, MD, PhD UH Angers
  More Information

No publications provided

Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT01212393     History of Changes
Other Study ID Numbers: PHRC 2008-02
Study First Received: September 29, 2010
Last Updated: May 21, 2014
Health Authority: France: Institutional Ethical Committee

Keywords provided by University Hospital, Angers:
venous thromboembolism disease
emergency
prevention
thromboprophylaxis
medical
hosptitalization
health care risks

Additional relevant MeSH terms:
Emergencies
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Disease Attributes
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis

ClinicalTrials.gov processed this record on August 21, 2014