Clinical trial NCT05019092: Systematic Screening for Deep Vein Thrombosis in Critically Ill Patients
Official title: Potential Harms and Benefits of Systematic Screening for Deep Vein Thrombosis in Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Deep Vein Thrombosis
Lead sponsor: University Of Perugia
Sponsor class: OTHER
First posted: 2021-08-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of deep vein thrombosis
timeFrame: hospitalization in UTI, an average of 10 days
Secondary outcomes:
measure: Progression of deep vein thrombosis (DVT)
timeFrame: hospitalization in UTI, an average of 10 days
measure: Prophylaxis/ treatment of venous thromboembolism (VTE)
timeFrame: hospitalization in UTI, an average of 10 days
measure: Incidence of pulmonary embolism
timeFrame: hospitalization in UTI, an average of 10 days
measure: Occurrence of major bleeding
timeFrame: hospitalization in UTI, an average of 10 days
measure: Occurrence of anemia
timeFrame: hospitalization in UTI, an average of 10 days
measure: Duration of ICU stay
timeFrame: hospitalization in UTI, an average of 10 days
measure: Risk of death in ICU
timeFrame: hospitalization in UTI, an average of 10 days
measure: Risk of death within 3 months after hospital discharge
timeFrame: Within 3 months after hospital discharge
measure: Risk of new hospital admission within 3 months after hospital discharge
timeFrame: Within 3 months after hospital discharge
Other outcomes:
Locations:
city: Perugia
country: Italy
facility: Medicine Interna, Angiologia e Malattie da arteriosclerosi
Study officials:
affiliation: University Of Perugia
name: Leonella Pasqualini, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.