Potential Harms and Benefits of Systematic Screening for Deep Vein Thrombosis in Critically Ill Patients
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Incidence of deep vein thrombosis
Study Overview
Brief Summary
Background: venous thromboembolism (VTE) is a common complication in critically ill patients, admitted to the Intensive Care Units (ICUs). At the present time, there is no validated score to estimate risks and benefits of antithrombotic pharmacological prophylaxis in this subset of patients.
Aim of the study: investigating potential harms and benefits of a protocol for systematic screening of DVT in critically ill patients, admitted to an ICU.
Expected relevance: systematic screening for deep vein thrombosis (DVT) through ultrasound (US) lower limb veins examination could help defining the indication to antithrombotic pharmacological treatment, but no protocol of systematic screening has been validated so far. Furthermore, the screening could be associated with over-diagnosis and consequent over-treatment, as well as increased management burden for the caregivers and higher healthcare costs.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age >18 years old
- •Admission to the ICU
Exclusion Criteria
- •duration of stay in ICU <5 days
- •SARS-CoV-2 infection
- •established DVT or pulmonary embolism at admission
- •established coagulation disorder
- •presence of inferior vena cava filter at the admission
- •admission/discharge to the ICU of another hospital
Outcomes
Primary Outcomes
Incidence of deep vein thrombosis
Time Frame: hospitalization in UTI, an average of 10 days
Diagnosis of deep vein thrombosis
Secondary Outcomes
- Duration of ICU stay(hospitalization in UTI, an average of 10 days)
- Progression of deep vein thrombosis (DVT)(hospitalization in UTI, an average of 10 days)
- Incidence of pulmonary embolism(hospitalization in UTI, an average of 10 days)
- Prophylaxis/ treatment of venous thromboembolism (VTE)(hospitalization in UTI, an average of 10 days)
- Occurrence of anemia(hospitalization in UTI, an average of 10 days)
- Occurrence of major bleeding(hospitalization in UTI, an average of 10 days)
- Risk of new hospital admission within 3 months after hospital discharge(Within 3 months after hospital discharge)
- Risk of death in ICU(hospitalization in UTI, an average of 10 days)
- Risk of death within 3 months after hospital discharge(Within 3 months after hospital discharge)
Investigators
Ettore Marini
Principal Investigator
University Of Perugia