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| Name | Class |
|---|---|
| Azienda Ospedaliera di Perugia | OTHER |
| Azienda Ospedaliera di Terni | UNKNOWN |
| Azienda Sanitaria Locale N.1 dell'Umbria | OTHER |
| USL Umbria 2 |
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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. Results of a pilot study showed that ultrasound (US) screening for deep vein thrombosis (DVT) is associated with a reduced incidence of proximal DVT, up front to an overall increased discovery rate of DVTs. The reduced incidence of proximal DVT could be attributed to an early diagnosis of distal and muscular DVTs, which would eventually receive a more adequate management. Proximal DVTs are associated with a worse long-term prognosis than distal or muscular DVTs, so it can be hypothesized that the active US screening could lead to an improvement of in-hospital and long-term prognosis of patients admitted to the ICU.
Aim of the study: to test whether an active US screening may reduce the incidence of proximal DVT and improve the in-hospital and long-term prognosis of patients admitted to the ICU.
Expected relevance: systematic screening for DVT could improve the management of the pharmacological antithrombotic treatment, leading to a reduction of thromboembolic and bleeding complications. This will eventually lead to an improved in-hospital and long-term prognosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screening | Experimental | Patients will receive an ultrasound screening for DVT between 48 to 96 hours after the admission to the intensive care. In case of negative ultrasound:
In case of positive ultrasound:
|
|
| Standard-of-care | Active Comparator | Ultrasound examination are performed according to clinical risk of DVT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound screening for lower limbs DVT | Diagnostic Test | Using a linear ultrasound probe (7.5-12 MHz) a compression ultrasound of the lower limbs is performed, from the hip to the ankle. The exam is completed by the use of Doppler. |
| Measure | Description | Time Frame |
|---|---|---|
| Proximal deep vein thrombosis | Deep vein thrombosis located above the popliteal area | Within 48-72 hours after admission to ICU |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality in ICU | Death rate during the hospitalization in ICU | From admission to ICU until the date of death from any cause or transfer to other facility, assessed up to 30 days |
| In-hospital mortality |
| Measure | Description | Time Frame |
|---|---|---|
| Major bleeding | Clinically relevant bleeding | From admission to ICU until the date of death from any cause or transfer to other facility, assessed up to 30 days |
| Anemization | Hemoglobin reduction >2 g/dL or need for transfusion during the ICU stay |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leonella Pasqualini, MD | Contact | +390755784030 | leonella.pasqualini@unipg.it |
| Name | Affiliation | Role |
|---|---|---|
| Leonella Pasqualini, MD | University Of Perugia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Sanitaria Locale N.1 dell'Umbria | Recruiting | Città di Castello | 06012 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35830171 | Background | Bikdeli B, Caraballo C, Trujillo-Santos J, Galanaud JP, di Micco P, Rosa V, Cusido GV, Schellong S, Mellado M, Del Valle Morales M, Gavin-Sebastian O, Mazzolai L, Krumholz HM, Monreal M; RIETE Investigators. Clinical Presentation and Short- and Long-term Outcomes in Patients With Isolated Distal Deep Vein Thrombosis vs Proximal Deep Vein Thrombosis in the RIETE Registry. JAMA Cardiol. 2022 Aug 1;7(8):857-865. doi: 10.1001/jamacardio.2022.1988. | |
| 36044159 |
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IPD are available on motivated request to the principal investigator
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2025-2035
motivated request to the principal investigator
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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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| UNKNOWN |
Multicenter trial, involving 2 intervention arms: screening and standard-of-care.
Centers are randomly allocated to provide the screening or the standard-of-care.
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Enrolling centers are blinded to each others. Investigators are blinded to centers allocation.
| Standard-of-care | Diagnostic Test | Ultrasound examination of lower limbs is performed according to clinical risk of DVT |
|
Death rate during the overall hospital stay
| From admission to ICU until the date of death from any cause or discharge, assessed up to 30 days |
| 90-day mortality | Death rate within 90 days after the admission to the ICU | Within 90 days after the admission of the ICU |
| From admission to ICU until the date of death from any cause or transfer to other facility, assessed up to 30 days |
| Pulmonary embolism | Pulmonary embolism diagnosed by chest CT | From admission to ICU until the date of death from any cause or transfer to other facility, assessed up to 30 days |
| Azienda Sanitaria Locale N.2 dell'Umbria | Recruiting | Foligno | 06034 | Italy |
|
| Azienda Sanitaria Locale N.1 dell'Umbria | Recruiting | Gubbio | 06024 | Italy |
|
| Azienda Ospedaliera di Perugia | Recruiting | Perugia | 06123 | Italy |
|
| Azienda Ospedaliera di Terni | Recruiting | Terni | 05100 | Italy |
|
| Result |
| 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. |