Prevention of Venous Thromboembolism Disease in Emergency Departments (PREVENU)

• Symptomatic venous thromboembolic events and severe haemorrhage [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

  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.

  
  

• Rate of symptomatic venous thromboembolic events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  - 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
  
  
• Rate of thromboembolic events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  - 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
  
  
• rate of severe haemorrhage [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  - 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
  
  
• appropriateness of thromboprophylaxis [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

  - 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

  
  

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