NCT06246604

Screening for Deep Vein Thrombosis in Intensive Care

Ultrasound Screening for Asymptomatic Deep Vein Thrombosis in Critically Ill Patient: a Multicenter Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,300 (estimated)
• Sponsor: University Of Perugia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Deep Vein Thrombosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Ultrasound 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_TEST	Standard-of-care	Ultrasound examination of lower limbs is performed according to clinical risk of DVT

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-10-31
• Completion: 2024-12-31
• First posted: 2024-02-07
• Last updated: 2024-02-07

Locations

5 sites across 1 country: Italy