Prevention of Venous Thromboembolism Disease in Emergency Departments (PREVENU)

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Design

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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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	40 Years and older (Adult, Senior)
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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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 History of Changes
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:

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