Clinical trial NCT04439383: Risk Stratification for Venous Thromboembolism in Hospitalized Medical Patients
Official title: Risk Stratification for Hospital-Acquired Venous Thromboembolism in Medical Patients: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Venous Thromboses
Pulmonary Embolism
Deep Vein Thrombosis
Embolism and Thrombosis
Mobility Limitation
Hospital Acquired Condition
Keywords: Venous thromboembolism
Pulmonary embolism
Deep vein thrombosis
Risk factor
Hospital-acquired
Mobility
Accelerometry
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire Vaudois
name: University Hospital, Geneva
name: University of Bern
First posted: 2020-06-19
Enrollment: 1353
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Venous thromboembolism
timeFrame: Within 90 days of initial hospital admission
Secondary outcomes:
measure: Venous thromboembolism
timeFrame: During the initial hospitalization, an average of 7 days
measure: All-cause mortality
timeFrame: During hospitalization (an average of 7 days) and up to 90 days of initial hospital admission
measure: Major bleeding
timeFrame: During hospitalization (an average of 7 days) and up to 90 days of initial hospital admission
measure: Clinically relevant non-major bleeding
timeFrame: During hospitalization (an average of 7 days) and up to 90 days of initial hospital admission
measure: Patient autonomy in the activities of daily living
timeFrame: At discharge (an average of 7 days after initial hospital admission) and at 90 days after admission
measure: Length of hospital stay
timeFrame: within 90 days of initial hospital admission
measure: Subsequent hospitalizations
timeFrame: Within 90 days of initial hospital admission
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital, Bern University Hospital
city: Geneva
country: Switzerland
facility: Geneva University Hospital
city: Lausanne
country: Switzerland
facility: University Hospital of Lausanne
Study officials:
affiliation: Inselspital, Bern University Hospital
name: Christine Baumgartner, MD, MAS
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Universitaire Vaudois, University Hospital of Lausanne
name: Marie Méan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.