Clinical trial NCT06246604: Screening for Deep Vein Thrombosis in Intensive Care
Official title: Ultrasound Screening for Asymptomatic Deep Vein Thrombosis in Critically Ill Patient: a Multicenter Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Deep Vein Thrombosis
Lead sponsor: University Of Perugia
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliera di Perugia
name: Azienda Ospedaliera di Terni
name: Azienda Sanitaria Locale N.1 dell'Umbria
name: USL Umbria 2
First posted: 2024-02-07
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter trial, involving 2 intervention arms: screening and standard-of-care.

Centers are randomly allocated to provide the screening or the standard-of-care.
Primary purpose: DIAGNOSTIC

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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Proximal deep vein thrombosis
timeFrame: Within 48-72 hours after admission to ICU
Secondary outcomes:
measure: Mortality in ICU
timeFrame: From admission to ICU until the date of death from any cause or transfer to other facility, assessed up to 30 days
measure: In-hospital mortality
timeFrame: From admission to ICU until the date of death from any cause or discharge, assessed up to 30 days
measure: 90-day mortality
timeFrame: Within 90 days after the admission of the ICU
Other outcomes:
measure: Major bleeding
timeFrame: From admission to ICU until the date of death from any cause or transfer to other facility, assessed up to 30 days
measure: Anemization
timeFrame: From admission to ICU until the date of death from any cause or transfer to other facility, assessed up to 30 days
measure: Pulmonary embolism
timeFrame: From admission to ICU until the date of death from any cause or transfer to other facility, assessed up to 30 days
Locations:
city: Città Di Castello
country: Italy
facility: Azienda Sanitaria Locale N.1 dell'Umbria
city: Foligno
country: Italy
facility: Azienda Sanitaria Locale N.2 dell'Umbria
city: Gubbio
country: Italy
facility: Azienda Sanitaria Locale N.1 dell'Umbria
city: Perugia
country: Italy
facility: Azienda Ospedaliera di Perugia
city: Terni
country: Italy
facility: Azienda Ospedaliera di Terni
Study officials:
affiliation: University Of Perugia
name: Leonella Pasqualini, MD
role: STUDY_DIRECTOR
References:
citation: Bikdeli B, Caraballo C, Trujillo-Santos J, Galanaud JP, di Micco P, Rosa V, Cusido GV, Schellong S, Mellado M, Del Valle Morales M, Gavin-Sebastian O, Mazzolai L, Krumholz HM, Monreal M; RIETE Investigators. Clinical Presentation and Short- and Long-term Outcomes in Patients With Isolated Distal Deep Vein Thrombosis vs Proximal Deep Vein Thrombosis in the RIETE Registry. JAMA Cardiol. 2022 Aug 1;7(8):857-865. doi: 10.1001/jamacardio.2022.1988.
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.