Prevention of Venous Thromboembolism Disease in Emergency Departments (PREVENU)
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Purpose
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 | Intervention |
|---|---|
|
Quality of Health Care |
Behavioral: reminders |
| Study Type: | Observational |
| Study Design: | 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. |
- 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
Biospecimen Retention: None Retained
| Enrollment: | 20000 |
| Study Start Date: | September 2009 |
| Study Completion Date: | June 2013 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 40 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01212393
| 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 | |
| Principal Investigator: | Pierre-Marie ROY, MD, PhD | UH Angers |
More Information
| Responsible Party: | University Hospital, Angers |
| ClinicalTrials.gov Identifier: | NCT01212393 History of Changes |
| Other Study ID Numbers: | PHRC 2008-02 |
| Study First Received: | September 29, 2010 |
| Last Updated: | May 21, 2014 |
| Health Authority: | France: Institutional Ethical Committee |
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 |
ClinicalTrials.gov processed this record on September 23, 2016