Systematic Screening for Deep Vein Thrombosis in Critically Ill Patients

Study Overview
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Brief Summary
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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.

Official Title
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Potential Harms and Benefits of Systematic Screening for Deep Vein Thrombosis in Critically Ill Patients

Conditions
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Deep Vein Thrombosis

Intervention / Treatment
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* Diagnostic Test: Ultrasound examination of lower limb veins


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Screening<br>Ultrasound (US) examination of lower limbs 48 hours after admission and again after 3-5 days (5-7 days after the admission) | Diagnostic Test: Ultrasound examination of lower limb veins<br>* Ultrasound examination will be performed by trained physicians using a commercially available ultrasound system and 5.0-15.0 MHz linear probe. The examinations consists of a comprehensive B-mode ultrasound protocol, from thigh to ankle, employing compression and color-Doppler at selected sites, according to the Consensus Conference of the Society of Radiologists in Ultrasound.<br>|
| No Intervention: Control<br>Ultrasound (US) examination according to the clinical evaluation of risk factors for deep vein thrombosis (DVT) and life-threatening bleeding, based on the standard of care (SOC) of the enrolling institution. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of deep vein thrombosis | Diagnosis of deep vein thrombosis | hospitalization in UTI, an average of 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression of deep vein thrombosis (DVT) | Extension of a previously diagnosed DVT to a more proximal site | hospitalization in UTI, an average of 10 days | 
| Prophylaxis/ treatment of venous thromboembolism (VTE) | Necessity of prophylaxis/ treatment of VTE and its possible modifications during the stay in Intensive Care Unit | hospitalization in UTI, an average of 10 days | 
| Incidence of pulmonary embolism | Findings of pulmonary embolism at contrast-enhanced CT scan | hospitalization in UTI, an average of 10 days | 
| Occurrence of major bleeding | According to the definition of the International Society of Thrombosis and Hemostasis | hospitalization in UTI, an average of 10 days | 
| Occurrence of anemia | Reduction of hemoglobin >2 g/dL without evidence of active bleeding | hospitalization in UTI, an average of 10 days | 
| Duration of ICU stay | Duration of ICU stay | hospitalization in UTI, an average of 10 days | 
| Risk of death in ICU | Death | hospitalization in UTI, an average of 10 days | 
| Risk of death within 3 months after hospital discharge | Death | Within 3 months after hospital discharge | 
| Risk of new hospital admission within 3 months after hospital discharge | New hospital admission | Within 3 months after hospital discharge |