Systematic Screening for Deep Vein Thrombosis in Critically Ill Patients
- Conditions
- Deep Vein Thrombosis
- Registration Number
- NCT05019092
- Lead Sponsor
- Ettore Marini
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- Age >18 years old
- Admission to the ICU
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Incidence of deep vein thrombosis hospitalization in UTI, an average of 10 days Diagnosis of deep vein thrombosis
- Secondary Outcome Measures
Name Time Method Duration of ICU stay hospitalization in UTI, an average of 10 days Duration of ICU stay
Progression of deep vein thrombosis (DVT) hospitalization in UTI, an average of 10 days Extension of a previously diagnosed DVT to a more proximal site
Incidence of pulmonary embolism hospitalization in UTI, an average of 10 days Findings of pulmonary embolism at contrast-enhanced CT scan
Prophylaxis/ treatment of venous thromboembolism (VTE) hospitalization in UTI, an average of 10 days Necessity of prophylaxis/ treatment of VTE and its possible modifications during the stay in Intensive Care Unit
Occurrence of anemia hospitalization in UTI, an average of 10 days Reduction of hemoglobin \>2 g/dL without evidence of active bleeding
Occurrence of major bleeding hospitalization in UTI, an average of 10 days According to the definition of the International Society of Thrombosis and Hemostasis
Risk of new hospital admission within 3 months after hospital discharge Within 3 months after hospital discharge New hospital admission
Risk of death in ICU hospitalization in UTI, an average of 10 days Death
Risk of death within 3 months after hospital discharge Within 3 months after hospital discharge Death
Trial Locations
- Locations (1)
Medicine Interna, Angiologia e Malattie da arteriosclerosi
🇮🇹Perugia, Italy
Medicine Interna, Angiologia e Malattie da arteriosclerosi🇮🇹Perugia, Italy