Screening for Deep Vein Thrombosis in Intensive Care

Deep Vein Thrombosis Clinical Trial

— DVT_ICU2  

Official title:

Ultrasound Screening for Asymptomatic Deep Vein Thrombosis in Critically Ill Patient: a Multicenter Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06246604
• Other study ID #: DVT_ICU2
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: University Of Perugia
• Contact: Leonella Pasqualini, MD
• Phone: +390755784030
• Email: leonella.pasqualini[@]unipg.it
• 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1300
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Diagnostic Test:
• Ultrasound screening for lower limbs DVT
Using a linear ultrasound probe (7.5-12 MHz) a compression ultrasound of the lower limbs is performed, from the hip to the ankle. The exam is completed by the use of Doppler.
• Standard-of-care
Ultrasound examination of lower limbs is performed according to clinical risk of DVT

Locations

Country	Name	City	State
Italy	Azienda Sanitaria Locale N.1 dell'Umbria	Città Di Castello
Italy	Azienda Sanitaria Locale N.2 dell'Umbria	Foligno
Italy	Azienda Sanitaria Locale N.1 dell'Umbria	Gubbio
Italy	Azienda Ospedaliera di Perugia	Perugia
Italy	Azienda Ospedaliera di Terni	Terni

Sponsors (5)

Lead Sponsor	Collaborator
University Of Perugia	Azienda Ospedaliera di Perugia, Azienda Ospedaliera di Terni, Azienda Sanitaria Locale N.1 dell'Umbria, USL Umbria 2

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Major bleeding	Clinically relevant bleeding	From admission to ICU until the date of death from any cause or transfer to other facility, assessed up to 30 days
Other	Anemization	Hemoglobin reduction >2 g/dL or need for transfusion during the ICU stay	From admission to ICU until the date of death from any cause or transfer to other facility, assessed up to 30 days
Other	Pulmonary embolism	Pulmonary embolism diagnosed by chest CT	From admission to ICU until the date of death from any cause or transfer to other facility, assessed up to 30 days
Primary	Proximal deep vein thrombosis	Deep vein thrombosis located above the popliteal area	Within 48-72 hours after admission to ICU
Secondary	Mortality in ICU	Death rate during the hospitalization in ICU	From admission to ICU until the date of death from any cause or transfer to other facility, assessed up to 30 days
Secondary	In-hospital mortality	Death rate during the overall hospital stay	From admission to ICU until the date of death from any cause or discharge, assessed up to 30 days
Secondary	90-day mortality	Death rate within 90 days after the admission to the ICU	Within 90 days after the admission of the ICU