Prevention of Venous Thromboembolism Disease in Emergency Departments (PREVENU)

• ClinicalTrials.gov Identifier: NCT01212393
• Recruitment Status: Completed
• First Posted: September 30, 2010
• Last Update Posted: April 6, 2018
• Sponsor: University Hospital, Angers
• Information provided by (Responsible Party): University Hospital, Angers

Study Description

Brief 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.

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 or disease	Intervention/treatment
Quality of Health Care	Behavioral: reminders

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

Study Design

• Study Type: Observational
• Actual Enrollment: 20000 participants
• Observational Model: Other
• 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.
• Study Start Date: September 2009
• Actual Primary Completion Date: March 2011
• Actual Study Completion Date: June 2013

Groups and Cohorts

Group/Cohort	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Symptomatic venous thromboembolic events and severe haemorrhage [ Time Frame: 3 months ]

   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 :

1. Rate of symptomatic venous thromboembolic events [ Time Frame: 3 months ]
   - 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
2. Rate of thromboembolic events [ Time Frame: 3 months ]
   - 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
3. rate of severe haemorrhage [ Time Frame: 3 months ]
   - 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
4. appropriateness of thromboprophylaxis [ Time Frame: 3 months ]

   - 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

Eligibility Criteria

• Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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 la pitié salpetriere

Paris, France, 75651

H Cochin

Paris, France

UH Bichat

Paris, France

UH Hotel Dieu

Paris, France

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Roy PM, Rachas A, Meyer G, Le Gal G, Durieux P, El Kouri D, Honnart D, Schmidt J, Legall C, Hausfater P, Chrétien 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.

• Responsible Party: University Hospital, Angers
• ClinicalTrials.gov Identifier: NCT01212393
• Other Study ID Numbers: PHRC 2008-02
• First Posted: September 30, 2010
• Last Update Posted: April 6, 2018
• Last Verified: December 2016

Keywords provided by University Hospital, Angers:

venous thromboembolism disease; emergency; prevention; thromboprophylaxis; medical; hosptitalization; health care risks

Additional relevant MeSH terms:

Thromboembolism; Venous Thromboembolism; Emergencies; Disease Attributes; Pathologic Processes; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases