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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screening | Experimental | Ultrasound (US) examination of lower limbs 48 hours after admission and again after 3-5 days (5-7 days after the admission) |
|
| Control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound examination of lower limb veins | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of deep vein thrombosis | Diagnosis of deep vein thrombosis | hospitalization in UTI, an average of 10 days |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leonella Pasqualini, MD | University Of Perugia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medicine Interna, Angiologia e Malattie da arteriosclerosi | Perugia | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36044159 | Derived | Tini G, Moriconi A, Ministrini S, Zullo V, Venanzi E, Mondovecchio G, Campanella T, Marini E, Bianchi M, Carbone F, Pirro M, De Robertis E, Pasqualini L. Ultrasound screening for asymptomatic deep vein thrombosis in critically ill patients: a pilot trial. Intern Emerg Med. 2022 Nov;17(8):2269-2277. doi: 10.1007/s11739-022-03085-8. Epub 2022 Aug 31. |
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Authors agree to share IPD after publication of results. Data will be access on request to the corresponding Author.
After publication of results
Available on request, by the corresponding author
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| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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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 |