RISE: Risk Stratification for Venous Thromboembolism in Hospitalized Medical Patients
Study Details
Study Description
Brief Summary
Hospital-acquired venous thromboembolism (HA-VTE) is one of the leading preventable causes of in-hospital mortality, but prevention of VTE in hospitalized medical patients remains challenging, as preventive measures such as pharmacological thromboprophylaxis (TPX) need to be tailored to individual thrombotic risk.
The broad objective of this project is to improve VTE prevention strategies in hospitalized medical patients by prospectively examining VTE risk factors (including mobility) and comparing existing risk assessment models.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- Venous thromboembolism [Within 90 days of initial hospital admission]
Symptomatic, objectively confirmed fatal and non-fatal hospital-acquired venous thromboembolism, including symptomatic distal and proximal deep vein thrombosis and pulmonary embolism after hospital admission
Secondary Outcome Measures
- Venous thromboembolism [During the initial hospitalization, an average of 7 days]
Symptomatic, objectively confirmed fatal and non-fatal hospital-acquired venous thromboembolism, including symptomatic distal and proximal deep vein thrombosis and pulmonary embolism during hospitalization
- All-cause mortality [During hospitalization (an average of 7 days) and up to 90 days of initial hospital admission]
All-cause mortality (all causes of death will be considered)
- Major bleeding [During hospitalization (an average of 7 days) and up to 90 days of initial hospital admission]
Major bleeding will be defined as fatal bleeding, symptomatic bleeding at critical sites (intracranial, intraspinal, intraocular, retroperitoneal, intraarticular, pericardial, or intramuscular with compartment syndrome), or bleeding with a reduction of hemoglobin of at least 20 g/L or bleeding leading to transfusion of 2 or more units of packed red blood cells according to the definition of the International Society on Thrombosis and Haemostasis
- Clinically relevant non-major bleeding [During hospitalization (an average of 7 days) and up to 90 days of initial hospital admission]
Clinically relevant non-major bleeding, defined as overt bleeding that does not meet criteria for major bleeding but is associated with a medical intervention, unscheduled physician contact (visit or telephone call), or pain or impairment of activities of daily life
- Patient autonomy in the activities of daily living [At discharge (an average of 7 days after initial hospital admission) and at 90 days after admission]
Patient autonomy in the activities of daily living as assessed by the modified Barthel Index
- Length of hospital stay [within 90 days of initial hospital admission]
Length of hospital stay, defined as the time/date of discharge minus time/date of admission at the hospital ward
- Subsequent hospitalizations [Within 90 days of initial hospital admission]
Subsequent hospitalization, defined as hospital readmissions
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥18 years
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Admitted for hospitalization >24 hours on a general internal medicine ward
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Informed consent as documented by signature
Exclusion Criteria:
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Need for therapeutic anticoagulation (e.g., atrial fibrillation)
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Life expectancy <30 days
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Insufficient proficiency of the German or French language
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Unwilling to provide informed consent
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Prior enrolment in the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Inselspital, Bern University Hospital | Bern | Switzerland | ||
| 2 | Geneva University Hospital | Geneva | Switzerland | ||
| 3 | University Hospital of Lausanne | Lausanne | Switzerland |
Sponsors and Collaborators
- University Hospital Inselspital, Berne
- Centre Hospitalier Universitaire Vaudois
- University Hospital, Geneva
- University of Bern
Investigators
- Principal Investigator: Christine Baumgartner, MD, MAS, Inselspital, Bern University Hospital
- Principal Investigator: Marie Méan, MD, Centre Hospitalier Universitaire Vaudois, University Hospital of Lausanne
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RISE