Risk Stratification for Venous Thromboembolism in Hospitalized Medical Patients

Pulmonary Embolism Clinical Trial

— RISE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04439383
• Other study ID #: RISE
• Status: Completed
• Start date: June 22, 2020
• Est. completion date: April 1, 2022

Study information

• Verified date: April 2022
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1353
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Embolism
• Embolism and Thrombosis
• Hospital Acquired Condition
• Iatrogenic Disease
• Mobility Limitation
• Pulmonary Embolism
• Thromboembolism
• Thrombosis
• Venous Thromboembolism
• Venous Thromboses
• Venous Thrombosis

Locations

Country	Name	City	State
Switzerland	Inselspital, Bern University Hospital	Bern
Switzerland	Geneva University Hospital	Geneva
Switzerland	University Hospital of Lausanne	Lausanne

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	Centre Hospitalier Universitaire Vaudois, University Hospital, Geneva, University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Subsequent hospitalizations	Subsequent hospitalization, defined as hospital readmissions	Within 90 days of initial hospital admission