Systematic Screening for Deep Vein Thrombosis in Critically Ill Patients

NCT05019092 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-08-24

No results posted yet for this study

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.

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.

Conditions

  • Deep Vein Thrombosis

Interventions

DIAGNOSTIC_TEST

Ultrasound examination of lower limb veins

Ultrasound examination will be performed by trained physicians using a commercially available ultrasound system and 5.0-15.0 MHz linear probe. The examinations consists of a comprehensive B-mode ultrasound protocol, from thigh to ankle, employing compression and color-Doppler at selected sites, according to the Consensus Conference of the Society of Radiologists in Ultrasound.

Sponsors & Collaborators

  • Ettore Marini

    lead OTHER

Principal Investigators

  • Leonella Pasqualini, MD · University Of Perugia

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2021-06-30
Completion
2021-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05019092 on ClinicalTrials.gov