Systematic Screening for Deep Vein Thrombosis in Critically Ill Patients

Ettore Marini

Status: Unknown

Conditions: Deep Vein Thrombosis

Treatments: Diagnostic Test: Ultrasound examination of lower limb veins

Study type: Interventional

Funder types: Other

Identifiers

NCT05019092

TVP_UTI_1

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.

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >18 years old
• Admission to the ICU

Exclusion criteria

• duration of stay in ICU <5 days
• SARS-CoV-2 infection
• established DVT or pulmonary embolism at admission
• established coagulation disorder
• presence of inferior vena cava filter at the admission
• admission/discharge to the ICU of another hospital

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Screening

Experimental group

Description:

Ultrasound (US) examination of lower limbs 48 hours after admission and again after 3-5 days (5-7 days after the admission)

Treatment:

Diagnostic Test: Ultrasound examination of lower limb veins

Control

No Intervention group

Description:

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.