Clinical trial NCT01212393: Prevention of Venous Thromboembolism Disease in Emergency Departments
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Health Care
Keywords: venous thromboembolism disease
emergency
prevention
thromboprophylaxis
medical
hosptitalization
health care risks
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2010-09-30
Enrollment: 20000
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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

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

Primary outcomes:
measure: Symptomatic venous thromboembolic events and severe haemorrhage
timeFrame: 3 months
Secondary outcomes:
measure: Rate of symptomatic venous thromboembolic events
timeFrame: 3 months
measure: Rate of thromboembolic events
timeFrame: 3 months
measure: rate of severe haemorrhage
timeFrame: 3 months
measure: appropriateness of thromboprophylaxis
timeFrame: 3 months
Other outcomes:
Locations:
city: Agen
country: France
facility: UH Agen
city: Argenteuil
country: France
facility: H Argenteuil
city: Besançon
country: France
facility: UH Besançon
city: Bethune
country: France
facility: H Bethune
city: Bobigny
country: France
facility: H Bobigny
city: Boulogne Billancourt
country: France
facility: UH Ambroise Pare
city: Brest
country: France
facility: UH Brest
city: Chateauroux
country: France
facility: H Chateauroux
city: Clermont Ferrand
country: France
facility: H Clermont Ferrand
city: Compiegne
country: France
facility: H Compiegne
city: Dijon
country: France
facility: UH Dijon
city: Grenoble
country: France
facility: UH Grenoble
city: La Reunion
country: France
facility: UH La Reunion
city: Marseille
country: France
facility: UH Marseille
city: Metz
country: France
facility: UH Metz Thionville
city: Nantes
country: France
facility: UH Nantes
city: Nimes
country: France
facility: UH Nimes
city: Paris
country: France
facility: UH la pitié salpetriere
city: Paris
country: France
facility: H Cochin
city: Paris
country: France
facility: UH Bichat
city: Paris
country: France
facility: UH Hotel Dieu
city: Poitiers
country: France
facility: UH Poitiers
city: Rennes
country: France
facility: UH Rennes
Study officials:
affiliation: UH Angers
name: Pierre-Marie ROY, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.