Screening for Deep Vein Thrombosis in Intensive Care

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Description

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.

Targeted Conditions

Study Overview

Start Date
November 1, 2023
Completion Date
December 31, 2024
Enrollment
1300
Date Posted
February 7, 2024
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Azienda Sanitaria Locale N.1 dell'Umbria
Città Di Castello 06012, Italy

Azienda Sanitaria Locale N.2 dell'Umbria
Foligno 06034, Italy

Azienda Sanitaria Locale N.1 dell'Umbria
Gubbio 06024, Italy

Azienda Ospedaliera di Perugia
Perugia 06123, Italy

Azienda Ospedaliera di Terni
Terni 05100, Italy

Eligibility

Minimum Age (years)
18
Eligibility Criteria
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

Study Contact Info

Study Contact Name
Leonella Pasqualini, MD
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
NCTid (if applicable)
NCT06246604