Risk Stratification for Venous Thromboembolism in Hospitalized Medical Patients (RISE)

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

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.

Study Overview

• Status: Completed
• Conditions: Embolism and Thrombosis; Deep Vein Thrombosis; Venous Thromboembolism; Pulmonary Embolism; Mobility Limitation; Hospital Acquired Condition; Venous Thromboses

• Study Type: Observational
• Enrollment (Actual): 1353

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland
    • Inselspital, Bern University Hospital
  • Geneva, Switzerland
    • Geneva University Hospital
  • Lausanne, Switzerland
    • University Hospital of Lausanne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Acutely ill adult patients hospitalized for at least 24h in general internal medicine of the participating tertiary care hospitals

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Collaborators: University Hospital, Geneva; Centre Hospitalier Universitaire Vaudois; 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

Publications and helpful links

General Publications

• Choffat D, Farhoumand PD, Jaccard E, de la Harpe R, Kraege V, Benmachiche M, Gerber C, Leuzinger S, Podmore C, Truong MK, Dumans-Louis C, Marti C, Reny JL, Aujesky D, Rakovic D, Limacher A, Rossel JB, Baumgartner C, Mean M. Risk stratification for hospital-acquired venous thromboembolism in medical patients (RISE): Protocol for a prospective cohort study. PLoS One. 2022 May 24;17(5):e0268833. doi: 10.1371/journal.pone.0268833. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2020
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): April 1, 2022

Study Registration Dates

• First Submitted: June 15, 2020
• First Submitted That Met QC Criteria: June 17, 2020
• First Posted (Actual): June 19, 2020

Study Record Updates

• Last Update Posted (Actual): April 5, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Deep vein thrombosis; Accelerometry; Pulmonary embolism; Mobility; Venous thromboembolism; Risk factor; Hospital-acquired
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Embolism; Thrombosis; Venous Thrombosis; Thromboembolism; Venous Thromboembolism; Pulmonary Embolism; Mobility Limitation; Iatrogenic Disease; Embolism and Thrombosis
• Other Study ID Numbers: RISE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No