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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

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

Locations
Other Locations
Italy
Azienda Sanitaria Locale N.1 dell'Umbria
RECRUITING
Città Di Castello
Azienda Sanitaria Locale N.2 dell'Umbria
RECRUITING
Foligno
Azienda Sanitaria Locale N.1 dell'Umbria
RECRUITING
Gubbio
Azienda Ospedaliera di Perugia
RECRUITING
Perugia
Azienda Ospedaliera di Terni
RECRUITING
Terni
Contact Information
Primary
Leonella Pasqualini, MD
leonella.pasqualini@unipg.it
+390755784030
Time Frame
Start Date: 2023-11-01
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 1300
Treatments
Experimental: 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.
Active_comparator: Standard-of-care
Ultrasound examination are performed according to clinical risk of DVT
Sponsors
Leads: University Of Perugia
Collaborators: Azienda Ospedaliera di Terni, Azienda Sanitaria Locale N.1 dell'Umbria, Azienda Ospedaliera di Perugia, USL Umbria 2

This content was sourced from clinicaltrials.gov