Screening for Deep Vein Thrombosis in Intensive Care

NCT ID: NCT06246604

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2024-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

Screening

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.

Group Type: EXPERIMENTAL

Ultrasound screening for lower limbs DVT

Intervention Type: 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.

Standard-of-care

Ultrasound examination are performed according to clinical risk of DVT

Group Type: ACTIVE_COMPARATOR

Standard-of-care

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Standard-of-care

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

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliera di Perugia

OTHER

Sponsor Role: collaborator

Azienda Ospedaliera di Terni

UNKNOWN

Sponsor Role: collaborator

Azienda Sanitaria Locale N.1 dell'Umbria

OTHER

Sponsor Role: collaborator

USL Umbria 2

UNKNOWN

Sponsor Role: collaborator

University Of Perugia

OTHER

Sponsor Role: lead

Responsible Party

Stefano Ministrini

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Leonella Pasqualini, MD

Role: STUDY_DIRECTOR

University Of Perugia

Locations

Azienda Sanitaria Locale N.1 dell'Umbria

Città di Castello, , Italy

Site Status: RECRUITING

Azienda Sanitaria Locale N.2 dell'Umbria

Foligno, , Italy

Site Status: RECRUITING

Azienda Sanitaria Locale N.1 dell'Umbria

Gubbio, , Italy

Site Status: RECRUITING

Azienda Ospedaliera di Perugia

Perugia, , Italy

Site Status: RECRUITING

Azienda Ospedaliera di Terni

Terni, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Leonella Pasqualini, MD

Role: CONTACT

leonella.pasqualini@unipg.it

+390755784030

Facility Contacts

Lucia Norgiolini, MD

Role: primary

lucia.norgiolini@uslumbria1.it

+39 075 85091

Matteo Vissani, MD

Role: primary

matteo.vissani@uslumbria2.it

+39 0742 3391

Pierluigi Piergentili, MD

Role: primary

pierluigi.piergentili@uslumbria1.it

+390759270801

Edoardo De Robertis, MD

Role: primary

edoardo.derobertis@unipg.it

+390755786428

Rita Commissari, MD

Role: primary

r.commissari@aospterni.it

+3907442051

References

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.

Reference Type: BACKGROUND

PMID: 35830171 (View on PubMed)

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.

Reference Type: RESULT

PMID: 36044159 (View on PubMed)

Other Identifiers

DVT_ICU2

Identifier Type: -

Identifier Source: org_study_id