Screening for Deep Vein Thrombosis in Intensive Care

NCT06246604 | Unknown

• 1 other identifier: DVT_ICU2
• Study Type: interventional
• Target: 1,300
• Locations: 1 country
• Sites: 5

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.

Conditions

Deep Vein Thrombosis

Outcome Measures

Primary Outcomes (1)

• Proximal deep vein thrombosis

  Deep vein thrombosis located above the popliteal area

  Within 48-72 hours after admission to ICU

Secondary Outcomes (3)

• Mortality in ICU

  From admission to ICU until the date of death from any cause or transfer to other facility, assessed up to 30 days

• In-hospital mortality

  From admission to ICU until the date of death from any cause or discharge, assessed up to 30 days

• 90-day mortality

  Within 90 days after the admission of the ICU

Other Outcomes (3)

• Major bleeding

  From admission to ICU until the date of death from any cause or transfer to other facility, assessed up to 30 days

• Anemization

  From admission to ICU until the date of death from any cause or transfer to other facility, assessed up to 30 days

• Pulmonary embolism

  From admission to ICU until the date of death from any cause or transfer to other facility, assessed up to 30 days

Study Arms (2)

Screening

EXPERIMENTAL

Patients will receive an ultrasound screening for DVT between 48 to 96 hours after the admission to the intensive care. In case of negative ultrasound: * if the pharmacological thromboprophylaxis is NOT possible, ultrasound is repeated after 48-96 hours; * if the pharmacological thromboprophylaxis is possible, re-evaluation is warrant only in case of clinical changes. In case of positive ultrasound: * if the DVT is proximal, it must be treated according to guidelines. Re-evaluation is warranted only in case of clinical changes; * if the DVT is distal and a full or intermediate anti-thrombotic treatment is possible, re-evaluation is warrant only in case of clinical changes; * if the DVT is distal and a full or intermediate anti-thrombotic treatment is NOT possible, the ultrasound is repeated after 48-96 hours.

Diagnostic Test: Ultrasound screening for lower limbs DVT

Standard-of-care

ACTIVE COMPARATOR

Ultrasound examination are performed according to clinical risk of DVT

Diagnostic Test: Standard-of-care

Interventions

Ultrasound screening for lower limbs DVT DIAGNOSTIC_TEST

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.

Screening

Standard-of-care DIAGNOSTIC_TEST

Ultrasound examination of lower limbs is performed according to clinical risk of DVT

Standard-of-care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• any patient admitted to ICU with a length-of-stay in ICU \>96 hours

You may not qualify if:

• 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

Sponsors & Collaborators

• University Of Perugia: lead
• Azienda Ospedaliera di Perugia: collaborator
• Azienda Ospedaliera di Terni: collaborator
• Azienda Sanitaria Locale N.1 dell'Umbria: collaborator
• USL Umbria 2: collaborator

Study Sites (5)

Azienda Sanitaria Locale N.1 dell'Umbria

Città di Castello, 06012, Italy

RECRUITING

Azienda Sanitaria Locale N.2 dell'Umbria

Foligno, 06034, Italy

RECRUITING

Azienda Sanitaria Locale N.1 dell'Umbria

Gubbio, 06024, Italy

RECRUITING

Azienda Ospedaliera di Perugia

Perugia, 06123, Italy

RECRUITING

Azienda Ospedaliera di Terni

Terni, 05100, Italy

RECRUITING

Related 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.

  PMID: 35830171 BACKGROUND

• 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.

  PMID: 36044159 RESULT

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Leonella Pasqualini, MD

  University Of Perugia

  STUDY DIRECTOR

Central Study Contacts

Leonella Pasqualini, MD

CONTACT

+390755784030; leonella.pasqualini@unipg.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Enrolling centers are blinded to each others. Investigators are blinded to centers allocation.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: Multicenter trial, involving 2 intervention arms: screening and standard-of-care. Centers are randomly allocated to provide the screening or the standard-of-care.

Study Record Dates

• First Submitted: November 26, 2023
• First Posted: February 7, 2024
• Study Start: November 1, 2023
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: 2025-2035
• Access Criteria: motivated request to the principal investigator

Locations

IT (5)