Risk Stratification for Venous Thromboembolism in Hospitalized Medical Patients

Study Overview
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Brief Summary
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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.

Official Title
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Risk Stratification for Hospital-Acquired Venous Thromboembolism in Medical Patients: a Prospective Cohort Study

Conditions
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Mobility Limitation, Venous Thromboembolism, Venous Thromboses, Pulmonary Embolism, Deep Vein Thrombosis, Embolism and Thrombosis, Hospital Acquired Condition

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years Admitted for hospitalization >24 hours on a general internal medicine ward Informed consent as documented by signature Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Venous thromboembolism | 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 | Within 90 days of initial hospital admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Venous thromboembolism | Symptomatic, objectively confirmed fatal and non-fatal hospital-acquired venous thromboembolism, including symptomatic distal and proximal deep vein thrombosis and pulmonary embolism during hospitalization | During the initial hospitalization, an average of 7 days | 
| All-cause mortality | All-cause mortality (all causes of death will be considered) | During hospitalization (an average of 7 days) and up to 90 days of initial hospital admission | 
| Major bleeding | 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 | During hospitalization (an average of 7 days) and up to 90 days of initial hospital admission | 
| Clinically relevant non-major bleeding | 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 | During hospitalization (an average of 7 days) and up to 90 days of initial hospital admission | 
| Patient autonomy in the activities of daily living | Patient autonomy in the activities of daily living as assessed by the modified Barthel Index | At discharge (an average of 7 days after initial hospital admission) and at 90 days after admission | 
| Length of hospital stay | Length of hospital stay, defined as the time/date of discharge minus time/date of admission at the hospital ward | within 90 days of initial hospital admission | 
| Subsequent hospitalizations | Subsequent hospitalization, defined as hospital readmissions | Within 90 days of initial hospital admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Accelerometry, Venous thromboembolism, Pulmonary embolism, Deep vein thrombosis, Risk factor, Hospital-acquired, Mobility