Systematic Screening for Deep Vein Thrombosis in Critically Ill Patients

NCT05019092 | Unknown

• 1 other identifier: TVP_UTI_1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Incidence of deep vein thrombosis

  Diagnosis of deep vein thrombosis

  hospitalization in UTI, an average of 10 days

Secondary Outcomes (9)

• Progression of deep vein thrombosis (DVT)

  hospitalization in UTI, an average of 10 days

• Prophylaxis/ treatment of venous thromboembolism (VTE)

  hospitalization in UTI, an average of 10 days

• Incidence of pulmonary embolism

  hospitalization in UTI, an average of 10 days

• Occurrence of major bleeding

  hospitalization in UTI, an average of 10 days

• Occurrence of anemia

  hospitalization in UTI, an average of 10 days

Study Arms (2)

Screening

EXPERIMENTAL

Ultrasound (US) examination of lower limbs 48 hours after admission and again after 3-5 days (5-7 days after the admission)

Diagnostic Test: Ultrasound examination of lower limb veins

Control

NO INTERVENTION

Ultrasound (US) examination according to the clinical evaluation of risk factors for deep vein thrombosis (DVT) and life-threatening bleeding, based on the standard of care (SOC) of the enrolling institution.

Interventions

Ultrasound examination of lower limb veins DIAGNOSTIC_TEST

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.

Screening

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years old
• Admission to the ICU

You may not qualify if:

• duration of stay in ICU \<5 days
• SARS-CoV-2 infection
• established DVT or pulmonary embolism at admission
• established coagulation disorder
• presence of inferior vena cava filter at the admission
• admission/discharge to the ICU of another hospital

Sponsors & Collaborators

• Ettore Marini: lead

Study Sites (1)

Medicine Interna, Angiologia e Malattie da arteriosclerosi

Perugia, Italy

Location

Related Publications (1)

• Tini G, Moriconi A, Ministrini S, Zullo V, Venanzi E, Mondovecchio G, Campanella T, Marini E, Bianchi M, Carbone F, Pirro M, De Robertis E, Pasqualini L. Ultrasound screening for asymptomatic deep vein thrombosis in critically ill patients: a pilot trial. Intern Emerg Med. 2022 Nov;17(8):2269-2277. doi: 10.1007/s11739-022-03085-8. Epub 2022 Aug 31.

  PMID: 36044159 DERIVED

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Leonella Pasqualini, MD

  University Of Perugia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: August 24, 2021
• Study Start: January 1, 2021
• Primary Completion: June 30, 2021
• Study Completion: December 31, 2021
• Last Updated: August 24, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After publication of results
• Access Criteria: Available on request, by the corresponding author

Locations

IT (1)