Prevention of Venous Thromboembolism Disease in Emergency Departments

NCT01212393 | Completed DMC

• 1 other identifier: PHRC 2008-02
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 23

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.

Conditions

Quality of Health Care

Keywords

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

Outcome Measures

Primary Outcomes (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.

  3 months

Secondary Outcomes (4)

• Rate of symptomatic venous thromboembolic events

  3 months

• Rate of thromboembolic events

  3 months

• rate of severe haemorrhage

  3 months

• appropriateness of thromboprophylaxis

  3 months

Study Arms (2)

Intervention group

reminders

Behavioral: reminders

current practice group

no intervention

Interventions

reminders 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.

Intervention group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• patients less than 40 years old
• patients hospitalized in a facility which doesn't participate to the study
• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (23)

UH Agen

Agen, France

Location

H Argenteuil

Argenteuil, 95107, France

Location

UH Besançon

Besançon, 25000, France

Location

H Bethune

Béthune, 62408, France

Location

H Bobigny

Bobigny, France

Location

UH Ambroise Pare

Boulogne-Billancourt, 92100, France

Location

UH Brest

Brest, France

Location

H Chateauroux

Châteauroux, 36019, France

Location

H Clermont Ferrand

Clermont-Ferrand, France

Location

H Compiegne

Compiègne, 60200, France

Location

UH Dijon

Dijon, 21033, France

Location

UH Grenoble

Grenoble, 38043, France

Location

UH La Reunion

La Réunion, France

Location

UH Marseille

Marseille, France

Location

UH Metz Thionville

Metz, France

Location

UH Nantes

Nantes, 44100, France

Location

UH Nimes

Nîmes, France

Location

UH la pitié salpetriere

Paris, 75651, France

Location

H Cochin

Paris, France

Location

UH Bichat

Paris, France

Location

UH Hotel Dieu

Paris, France

Location

UH Poitiers

Poitiers, France

Location

UH Rennes

Rennes, France

Location

Related Publications (1)

• 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.

  PMID: 27227406 DERIVED

Biospecimen

Retention: NONE RETAINED

observational study at the patient level - cluster randomized study

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pierre-Marie ROY, MD, PhD

  UH Angers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2010
• First Posted: September 30, 2010
• Study Start: September 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: June 1, 2013
• Last Updated: April 6, 2018

Record last verified: 2016-12

Locations

FR (23)