Systematic Screening for Deep Vein Thrombosis in Critically Ill Patients

Potential Harms and Benefits of Systematic Screening for Deep Vein Thrombosis in Critically Ill Patients

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Deep Vein Thrombosis
• Intervention / Treatment: Diagnostic test: Ultrasound examination of lower limb veins

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Perugia, Italy
    • Medicine Interna, Angiologia e Malattie da arteriosclerosi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age >18 years old
• Admission to the ICU

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Screening; 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; 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.
No Intervention: Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of deep vein thrombosis	Diagnosis of deep vein thrombosis	hospitalization in UTI, an average of 10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression of deep vein thrombosis (DVT)	Extension of a previously diagnosed DVT to a more proximal site	hospitalization in UTI, an average of 10 days
Prophylaxis/ treatment of venous thromboembolism (VTE)	Necessity of prophylaxis/ treatment of VTE and its possible modifications during the stay in Intensive Care Unit	hospitalization in UTI, an average of 10 days
Incidence of pulmonary embolism	Findings of pulmonary embolism at contrast-enhanced CT scan	hospitalization in UTI, an average of 10 days
Occurrence of major bleeding	According to the definition of the International Society of Thrombosis and Hemostasis	hospitalization in UTI, an average of 10 days
Occurrence of anemia	Reduction of hemoglobin >2 g/dL without evidence of active bleeding	hospitalization in UTI, an average of 10 days
Duration of ICU stay	Duration of ICU stay	hospitalization in UTI, an average of 10 days
Risk of death in ICU	Death	hospitalization in UTI, an average of 10 days
Risk of death within 3 months after hospital discharge	Death	Within 3 months after hospital discharge
Risk of new hospital admission within 3 months after hospital discharge	New hospital admission	Within 3 months after hospital discharge

Collaborators and Investigators

• Sponsor: Ettore Marini
• Investigators: Principal Investigator: Leonella Pasqualini, MD, Università degli Studi di Perugia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): June 30, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: August 5, 2021
• First Submitted That Met QC Criteria: August 19, 2021
• First Posted (Actual): August 24, 2021

Study Record Updates

• Last Update Posted (Actual): August 24, 2021
• Last Update Submitted That Met QC Criteria: August 19, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis
• Other Study ID Numbers: TVP_UTI_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Authors agree to share IPD after publication of results. Data will be access on request to the corresponding Author.
• IPD Sharing Time Frame: After publication of results
• IPD Sharing Access Criteria: Available on request, by the corresponding author
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No