Prevention of Venous Thromboembolism Disease in Emergency Departments

NCT ID: NCT01212393

Last Updated: 2018-04-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2013-06-30

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.

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

Conditions

Quality of Health Care

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Intervention group

reminders

reminders

Intervention Type: BEHAVIORAL

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

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre-Marie ROY, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UH Angers

Locations

UH Agen

Agen, , France

H Argenteuil

Argenteuil, , France

UH Besançon

Besançon, , France

H Bethune

Béthune, , France

H Bobigny

Bobigny, , France

UH Ambroise Pare

Boulogne-Billancourt, , France

UH Brest

Brest, , France

H Chateauroux

Châteauroux, , France

H Clermont Ferrand

Clermont-Ferrand, , France

H Compiegne

Compiègne, , France

UH Dijon

Dijon, , France

UH Grenoble

Grenoble, , France

UH La Reunion

La Réunion, , France

UH Marseille

Marseille, , France

UH Metz Thionville

Metz, , France

UH Nantes

Nantes, , France

UH Nimes

Nîmes, , France

UH la pitié salpetriere

Paris, , France

H Cochin

Paris, , France

UH Bichat

Paris, , France

UH Hotel Dieu

Paris, , France

UH Poitiers

Poitiers, , France

UH Rennes

Rennes, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 27227406 (View on PubMed)

Other Identifiers

PHRC 2008-02

Identifier Type: -

Identifier Source: org_study_id