Systematic Screening for Deep Vein Thrombosis in Critically Ill Patients

• Sponsor: Ettore Marini (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05019092
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 8.4

Study Details

Study Description

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.

Aim of the study: investigating potential harms and benefits of a protocol for systematic screening of DVT in critically ill patients, admitted to an ICU.

Expected relevance: systematic screening for deep vein thrombosis (DVT) through ultrasound (US) lower limb veins examination could help defining the indication to antithrombotic pharmacological treatment, but no protocol of systematic screening has been validated so far. Furthermore, the screening could be associated with over-diagnosis and consequent over-treatment, as well as increased management burden for the caregivers and higher healthcare costs.

Condition or Disease	Intervention/Treatment	Phase
Deep Vein Thrombosis	Diagnostic Test: Ultrasound examination of lower limb veins	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Potential Harms and Benefits of Systematic Screening for Deep Vein Thrombosis in Critically Ill Patients
• Actual Study Start Date: Jan 1, 2021
• Actual Primary Completion Date: Jun 30, 2021
• Anticipated Study Completion Date: Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Screening Ultrasound (US) examination of lower limbs 48 hours after admission and again after 3-5 days (5-7 days after the admission)	Diagnostic Test: Ultrasound examination of lower limb veins; Ultrasound examination will be performed by trained physicians using a commercially available ultrasound system and 5.0-15.0 MHz linear probe. The examinations consists of a comprehensive B-mode ultrasound protocol, from thigh to ankle, employing compression and color-Doppler at selected sites, according to the Consensus Conference of the Society of Radiologists in Ultrasound.
No Intervention: Control Ultrasound (US) examination according to the clinical evaluation of risk factors for deep vein thrombosis (DVT) and life-threatening bleeding, based on the standard of care (SOC) of the enrolling institution.

Outcome Measures

Primary Outcome Measures

1. Incidence of deep vein thrombosis [hospitalization in UTI, an average of 10 days]

   Diagnosis of deep vein thrombosis

Secondary Outcome Measures

1. Progression of deep vein thrombosis (DVT) [hospitalization in UTI, an average of 10 days]

   Extension of a previously diagnosed DVT to a more proximal site

2. Prophylaxis/ treatment of venous thromboembolism (VTE) [hospitalization in UTI, an average of 10 days]

   Necessity of prophylaxis/ treatment of VTE and its possible modifications during the stay in Intensive Care Unit

3. Incidence of pulmonary embolism [hospitalization in UTI, an average of 10 days]

   Findings of pulmonary embolism at contrast-enhanced CT scan

4. Occurrence of major bleeding [hospitalization in UTI, an average of 10 days]

   According to the definition of the International Society of Thrombosis and Hemostasis

5. Occurrence of anemia [hospitalization in UTI, an average of 10 days]

   Reduction of hemoglobin >2 g/dL without evidence of active bleeding

6. Duration of ICU stay [hospitalization in UTI, an average of 10 days]

   Duration of ICU stay

7. Risk of death in ICU [hospitalization in UTI, an average of 10 days]

   Death

8. Risk of death within 3 months after hospital discharge [Within 3 months after hospital discharge]

   Death

9. Risk of new hospital admission within 3 months after hospital discharge [Within 3 months after hospital discharge]

   New hospital admission

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age >18 years old

• Admission to the ICU

Exclusion Criteria:

• duration of stay in ICU <5 days

• SARS-CoV-2 infection

• established DVT or pulmonary embolism at admission

• established coagulation disorder

• presence of inferior vena cava filter at the admission

• admission/discharge to the ICU of another hospital

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medicine Interna, Angiologia e Malattie da arteriosclerosi	Perugia		Italy

Sponsors and Collaborators

• Ettore Marini

Investigators

• Principal Investigator: Leonella Pasqualini, MD, Università degli Studi di Perugia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ettore Marini, Principal Investigator, University Of Perugia
• ClinicalTrials.gov Identifier: NCT05019092
• Other Study ID Numbers: TVP_UTI_1
• First Posted: Aug 24, 2021
• Last Update Posted: Aug 24, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Thrombosis; Venous Thrombosis

Study Results

No Results Posted as of Aug 24, 2021