Prevention of Venous Thromboembolism Disease in Emergency Departments

Quality of Health Care Clinical Trial

— PREVENU  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01212393
• Other study ID #: PHRC 2008-02
• Status: Completed
• First received: September 29, 2010
• Last updated: April 5, 2018
• Start date: September 2009
• Est. completion date: June 2013

Study information

• Verified date: December 2016
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20000
• Est. completion date: June 2013
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Quality of Health Care
• Thromboembolism
• Venous Thromboembolism

Intervention

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.

Locations

Country	Name	City	State
France	UH Agen	Agen
France	H Argenteuil	Argenteuil
France	UH Besançon	Besançon
France	H Bethune	Bethune
France	H Bobigny	Bobigny
France	UH Ambroise Pare	Boulogne Billancourt
France	UH Brest	Brest
France	H Chateauroux	Chateauroux
France	H Clermont Ferrand	Clermont Ferrand
France	H Compiegne	Compiegne
France	UH Dijon	Dijon
France	UH Grenoble	Grenoble
France	UH La Reunion	La Reunion
France	UH Marseille	Marseille
France	UH Metz Thionville	Metz
France	UH Nantes	Nantes
France	UH Nimes	Nimes
France	H Cochin	Paris
France	UH Bichat	Paris
France	UH Hotel Dieu	Paris
France	UH la pitié salpetriere	Paris
France	UH Poitiers	Poitiers
France	UH Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of symptomatic venous thromboembolic events	- 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	3 months
Secondary	Rate of thromboembolic events	- 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 months
Secondary	rate of severe haemorrhage	- 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	3 months
Secondary	appropriateness of thromboprophylaxis	- 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	3 months