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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04439383
Other study ID # RISE
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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