Risk Stratification for Venous Thromboembolism in Hospitalized Medical Patients
- Conditions
- Venous ThromboembolismPulmonary EmbolismDeep Vein ThrombosisMobility LimitationHospital Acquired ConditionVenous ThrombosesEmbolism and Thrombosis
- Registration Number
- NCT04439383
- Lead Sponsor
- Insel Gruppe AG, University Hospital Bern
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1353
- Age ≥18 years
- Admitted for hospitalization >24 hours on a general internal medicine ward
- Informed consent as documented by signature
- Need for therapeutic anticoagulation (e.g., atrial fibrillation)
- Life expectancy <30 days
- Insufficient proficiency of the German or French language
- Unwilling to provide informed consent
- Prior enrolment in the study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
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
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
Trial Locations
- Locations (3)
Geneva University Hospital
🇨🇭Geneva, Switzerland
Inselspital, Bern University Hospital
🇨🇭Bern, Switzerland
University Hospital of Lausanne
🇨🇭Lausanne, Switzerland