Screening for Deep Vein Thrombosis in Intensive Care (DVT_ICU2)

January 29, 2024 updated by: Stefano Ministrini, University Of Perugia

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Città Di Castello, Italy, 06012
      • Foligno, Italy, 06034
        • Recruiting
        • Azienda Sanitaria Locale N.2 dell'Umbria
        • Contact:
      • Gubbio, Italy, 06024
      • Perugia, Italy, 06123
        • Recruiting
        • Azienda Ospedaliera di Perugia
        • Contact:
      • Terni, Italy, 05100
        • Recruiting
        • Azienda Ospedaliera di Terni
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Screening

Patients will receive an ultrasound screening for DVT between 48 to 96 hours after the admission to the intensive care. In case of negative ultrasound:

  • if the pharmacological thromboprophylaxis is NOT possible, ultrasound is repeated after 48-96 hours;
  • if the pharmacological thromboprophylaxis is possible, re-evaluation is warrant only in case of clinical changes.

In case of positive ultrasound:

  • if the DVT is proximal, it must be treated according to guidelines. Re-evaluation is warranted only in case of clinical changes;
  • if the DVT is distal and a full or intermediate anti-thrombotic treatment is possible, re-evaluation is warrant only in case of clinical changes;
  • if the DVT is distal and a full or intermediate anti-thrombotic treatment is NOT possible, the ultrasound is repeated after 48-96 hours.
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.
Active Comparator: Standard-of-care
Ultrasound examination are performed according to clinical risk of DVT
Diagnostic test: Standard-of-care
Ultrasound examination of lower limbs is performed according to clinical risk of DVT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proximal deep vein thrombosis
Time Frame: Within 48-72 hours after admission to ICU
Deep vein thrombosis located above the popliteal area
Within 48-72 hours after admission to ICU

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality in ICU
Time Frame: From admission to ICU until the date of death from any cause or transfer to other facility, assessed up to 30 days
Death rate during the hospitalization in ICU
From admission to ICU until the date of death from any cause or transfer to other facility, assessed up to 30 days
In-hospital mortality
Time Frame: From admission to ICU until the date of death from any cause or discharge, assessed up to 30 days
Death rate during the overall hospital stay
From admission to ICU until the date of death from any cause or discharge, assessed up to 30 days
90-day mortality
Time Frame: Within 90 days after the admission of the ICU
Death rate within 90 days after the admission to the ICU
Within 90 days after the admission of the ICU

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major bleeding
Time Frame: From admission to ICU until the date of death from any cause or transfer to other facility, assessed up to 30 days
Clinically relevant bleeding
From admission to ICU until the date of death from any cause or transfer to other facility, assessed up to 30 days
Anemization
Time Frame: From admission to ICU until the date of death from any cause or transfer to other facility, assessed up to 30 days
Hemoglobin reduction >2 g/dL or need for transfusion during the ICU stay
From admission to ICU until the date of death from any cause or transfer to other facility, assessed up to 30 days
Pulmonary embolism
Time Frame: From admission to ICU until the date of death from any cause or transfer to other facility, assessed up to 30 days
Pulmonary embolism diagnosed by chest CT
From admission to ICU until the date of death from any cause or transfer to other facility, assessed up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Of Perugia

Collaborators

Azienda Ospedaliera di Perugia
Azienda Sanitaria Locale N.1 dell'Umbria
Azienda Ospedaliera di Terni
USL Umbria 2

Investigators

  • Study Director: Leonella Pasqualini, MD, University Of Perugia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

November 26, 2023

First Submitted That Met QC Criteria

January 29, 2024

First Posted (Estimated)

February 7, 2024

Study Record Updates

Last Update Posted (Estimated)

February 7, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DVT_ICU2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD are available on motivated request to the principal investigator

IPD Sharing Time Frame

2025-2035

IPD Sharing Access Criteria

motivated request to the principal investigator

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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