Systematic Screening for Deep Vein Thrombosis in Critically Ill Patients
Primary Purpose
Deep Vein Thrombosis
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Ultrasound examination of lower limb veins
Sponsored by
About this trial
This is an interventional screening trial for Deep Vein Thrombosis
Eligibility Criteria
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
Sites / Locations
- Medicine Interna, Angiologia e Malattie da arteriosclerosi
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Screening
Control
Arm Description
Ultrasound (US) examination of lower limbs 48 hours after admission and again after 3-5 days (5-7 days after the admission)
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.
Outcomes
Primary Outcome Measures
Incidence of deep vein thrombosis
Diagnosis of deep vein thrombosis
Secondary Outcome Measures
Progression of deep vein thrombosis (DVT)
Extension of a previously diagnosed DVT to a more proximal site
Prophylaxis/ treatment of venous thromboembolism (VTE)
Necessity of prophylaxis/ treatment of VTE and its possible modifications during the stay in Intensive Care Unit
Incidence of pulmonary embolism
Findings of pulmonary embolism at contrast-enhanced CT scan
Occurrence of major bleeding
According to the definition of the International Society of Thrombosis and Hemostasis
Occurrence of anemia
Reduction of hemoglobin >2 g/dL without evidence of active bleeding
Duration of ICU stay
Duration of ICU stay
Risk of death in ICU
Death
Risk of death within 3 months after hospital discharge
Death
Risk of new hospital admission within 3 months after hospital discharge
New hospital admission
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05019092
Brief Title
Systematic Screening for Deep Vein Thrombosis in Critically Ill Patients
Official Title
Potential Harms and Benefits of Systematic Screening for Deep Vein Thrombosis in Critically Ill Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ettore Marini
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Vein Thrombosis
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Screening
Arm Type
Experimental
Arm Description
Ultrasound (US) examination of lower limbs 48 hours after admission and again after 3-5 days (5-7 days after the admission)
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Ultrasound examination of lower limb veins
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of deep vein thrombosis
Description
Diagnosis of deep vein thrombosis
Time Frame
hospitalization in UTI, an average of 10 days
Secondary Outcome Measure Information:
Title
Progression of deep vein thrombosis (DVT)
Description
Extension of a previously diagnosed DVT to a more proximal site
Time Frame
hospitalization in UTI, an average of 10 days
Title
Prophylaxis/ treatment of venous thromboembolism (VTE)
Description
Necessity of prophylaxis/ treatment of VTE and its possible modifications during the stay in Intensive Care Unit
Time Frame
hospitalization in UTI, an average of 10 days
Title
Incidence of pulmonary embolism
Description
Findings of pulmonary embolism at contrast-enhanced CT scan
Time Frame
hospitalization in UTI, an average of 10 days
Title
Occurrence of major bleeding
Description
According to the definition of the International Society of Thrombosis and Hemostasis
Time Frame
hospitalization in UTI, an average of 10 days
Title
Occurrence of anemia
Description
Reduction of hemoglobin >2 g/dL without evidence of active bleeding
Time Frame
hospitalization in UTI, an average of 10 days
Title
Duration of ICU stay
Description
Duration of ICU stay
Time Frame
hospitalization in UTI, an average of 10 days
Title
Risk of death in ICU
Description
Death
Time Frame
hospitalization in UTI, an average of 10 days
Title
Risk of death within 3 months after hospital discharge
Description
Death
Time Frame
Within 3 months after hospital discharge
Title
Risk of new hospital admission within 3 months after hospital discharge
Description
New hospital admission
Time Frame
Within 3 months after hospital discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonella Pasqualini, MD
Organizational Affiliation
University Of Perugia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medicine Interna, Angiologia e Malattie da arteriosclerosi
City
Perugia
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Authors agree to share IPD after publication of results. Data will be access on request to the corresponding Author.
IPD Sharing Time Frame
After publication of results
IPD Sharing Access Criteria
Available on request, by the corresponding author
Citations:
PubMed Identifier
36044159
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. Intern Emerg Med. 2022 Nov;17(8):2269-2277. doi: 10.1007/s11739-022-03085-8. Epub 2022 Aug 31.
Results Reference
derived
Learn more about this trial
Systematic Screening for Deep Vein Thrombosis in Critically Ill Patients
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