Systematic Screening for Deep Vein Thrombosis in Critically Ill Patients

Deep Vein Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05019092
• Other study ID #: TVP_UTI_1
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2021
• Source: University Of Perugia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 31, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

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.

Locations

Country	Name	City	State
Italy	Medicine Interna, Angiologia e Malattie da arteriosclerosi	Perugia

Sponsors (1)

Lead Sponsor	Collaborator
Ettore Marini

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of deep vein thrombosis	Diagnosis of deep vein thrombosis	hospitalization in UTI, an average of 10 days
Secondary	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
Secondary	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
Secondary	Incidence of pulmonary embolism	Findings of pulmonary embolism at contrast-enhanced CT scan	hospitalization in UTI, an average of 10 days
Secondary	Occurrence of major bleeding	According to the definition of the International Society of Thrombosis and Hemostasis	hospitalization in UTI, an average of 10 days
Secondary	Occurrence of anemia	Reduction of hemoglobin >2 g/dL without evidence of active bleeding	hospitalization in UTI, an average of 10 days
Secondary	Duration of ICU stay	Duration of ICU stay	hospitalization in UTI, an average of 10 days
Secondary	Risk of death in ICU	Death	hospitalization in UTI, an average of 10 days
Secondary	Risk of death within 3 months after hospital discharge	Death	Within 3 months after hospital discharge
Secondary	Risk of new hospital admission within 3 months after hospital discharge	New hospital admission	Within 3 months after hospital discharge