Deep Vein Thrombosis
Conditions
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.
Interventions
DIAGNOSTIC_TESTUltrasound examination of lower limb veins
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.
Sponsors
Ettore Marini
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of deep vein thrombosis | hospitalization in UTI, an average of 10 days | Diagnosis of deep vein thrombosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Incidence of pulmonary embolism | hospitalization in UTI, an average of 10 days | Findings of pulmonary embolism at contrast-enhanced CT scan |
| Occurrence of major bleeding | hospitalization in UTI, an average of 10 days | According to the definition of the International Society of Thrombosis and Hemostasis |
| Occurrence of anemia | hospitalization in UTI, an average of 10 days | Reduction of hemoglobin \>2 g/dL without evidence of active bleeding |
| 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 |
| 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 |
| Risk of new hospital admission within 3 months after hospital discharge | Within 3 months after hospital discharge | New hospital admission |
| Duration of ICU stay | hospitalization in UTI, an average of 10 days | Duration of ICU stay |
Countries
Italy
Outcome results
None listed