Screening for Deep Vein Thrombosis in Intensive Care

NCT06246604 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1300

Last updated 2024-02-07

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. 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

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

Sponsors & Collaborators

  • Azienda Ospedaliera di Perugia

    collaborator OTHER
  • Azienda Ospedaliera di Terni

    collaborator UNKNOWN
  • Azienda Sanitaria Locale N.1 dell'Umbria

    collaborator OTHER
  • USL Umbria 2

    collaborator UNKNOWN
  • University Of Perugia

    lead OTHER

Principal Investigators

  • Leonella Pasqualini, MD · University Of Perugia

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2024-10-31
Completion
2024-12-31

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 NCT06246604 on ClinicalTrials.gov