Screening for Deep Vein Thrombosis in Intensive Care
- Conditions
- Deep Vein Thrombosis
- Interventions
- Diagnostic Test: Ultrasound screening for lower limbs DVTDiagnostic Test: Standard-of-care
- Registration Number
- NCT06246604
- Lead Sponsor
- University Of Perugia
- 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1300
- any patient admitted to ICU with a length-of-stay in ICU >96 hours
- pregnancy
- SARS-CoV-2 infection
- established DVT or pulmonary embolism at admission
- established coagulation disorder
- presence of inferior vena cava filter at the admission
- admission from the ICU of another hospital
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Screening Ultrasound screening for lower limbs DVT 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: * if the pharmacological thromboprophylaxis is NOT possible, ultrasound is repeated after 48-96 hours; * if the pharmacological thromboprophylaxis is possible, re-evaluation is warrant only in case of clinical changes. In case of positive ultrasound: * if the DVT is proximal, it must be treated according to guidelines. Re-evaluation is warranted only in case of clinical changes; * if the DVT is distal and a full or intermediate anti-thrombotic treatment is possible, re-evaluation is warrant only in case of clinical changes; * if the DVT is distal and a full or intermediate anti-thrombotic treatment is NOT possible, the ultrasound is repeated after 48-96 hours. Standard-of-care Standard-of-care Ultrasound examination are performed according to clinical risk of DVT
- Primary Outcome Measures
Name Time Method Proximal deep vein thrombosis Within 48-72 hours after admission to ICU Deep vein thrombosis located above the popliteal area
- Secondary Outcome Measures
Name Time Method Mortality in ICU From admission to ICU until the date of death from any cause or transfer to other facility, assessed up to 30 days Death rate during the hospitalization in ICU
In-hospital mortality From admission to ICU until the date of death from any cause or discharge, assessed up to 30 days Death rate during the overall hospital stay
90-day mortality Within 90 days after the admission of the ICU Death rate within 90 days after the admission to the ICU
Trial Locations
- Locations (4)
Azienda Sanitaria Locale N.1 dell'Umbria
🇮🇹Gubbio, Italy
Azienda Sanitaria Locale N.2 dell'Umbria
🇮🇹Foligno, Italy
Azienda Ospedaliera di Perugia
🇮🇹Perugia, Italy
Azienda Ospedaliera di Terni
🇮🇹Terni, Italy