Screening for Deep Vein Thrombosis in Intensive Care (DVT_ICU2)

University Of Perugia

Status

Enrolling

Conditions

Deep Vein Thrombosis

Treatments

Diagnostic Test: Standard-of-care

Diagnostic Test: Ultrasound screening for lower limbs DVT

Study type

Interventional

Funder types

Other

Identifiers

NCT06246604

DVT_ICU2

Details and patient eligibility

About

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.

Enrollment

1,300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

1,300 participants in 2 patient groups

Screening

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Ultrasound screening for lower limbs DVT

Standard-of-care

Active Comparator group

Description:

Ultrasound examination are performed according to clinical risk of DVT

Treatment:

Diagnostic Test: Standard-of-care