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. 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.
Interventions
DIAGNOSTIC_TESTUltrasound screening for lower limbs DVT
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.
DIAGNOSTIC_TESTStandard-of-care
Ultrasound examination of lower limbs is performed according to clinical risk of DVT
Sponsors
Azienda Ospedaliera di Perugia
Azienda Ospedaliera di Terni
Azienda Sanitaria Locale N.1 dell'Umbria
USL Umbria 2
University Of Perugia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
Enrolling centers are blinded to each others. Investigators are blinded to centers allocation.
Intervention model description
Multicenter trial, involving 2 intervention arms: screening and standard-of-care. Centers are randomly allocated to provide the screening or the standard-of-care.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* any patient admitted to ICU with a length-of-stay in ICU \>96 hours
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proximal deep vein thrombosis | Within 48-72 hours after admission to ICU | Deep vein thrombosis located above the popliteal area |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Anemization | From admission to ICU until the date of death from any cause or transfer to other facility, assessed up to 30 days | Hemoglobin reduction \>2 g/dL or need for transfusion during the ICU stay |
| Pulmonary embolism | From admission to ICU until the date of death from any cause or transfer to other facility, assessed up to 30 days | Pulmonary embolism diagnosed by chest CT |
| Major bleeding | From admission to ICU until the date of death from any cause or transfer to other facility, assessed up to 30 days | Clinically relevant bleeding |
Countries
Italy
Contacts
Primary ContactLeonella Pasqualini, MD
Outcome results
None listed