Deep Vein ThrombosisNCT05019092
Systematic Screening for Deep Vein Thrombosis in Critically Ill Patients
A study testing Ultrasound examination of lower limb veins in people with Deep Vein Thrombosis, run by Ettore Marini at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Vein Thrombosis
- What is being tested?
- Ultrasound examination of lower limb veins
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years old
- Admission to the ICU
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Potential Harms and Benefits of Systematic Screening for Deep Vein Thrombosis in Critically Ill Patients
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.
- Conditions
- Deep Vein Thrombosis
- Being tested
- Ultrasound examination of lower limb veins
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound examination of lower limb veinsDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Screening | Experimental | Ultrasound (US) examination of lower limbs 48 hours after admission and again after 3-5 days (5-7 days after the admission) Receives: Diagnostic Test: Ultrasound examination of lower limb veins |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of deep vein thrombosis
Diagnosis of deep vein thrombosis
Measured: hospitalization in UTI, an average of 10 days
Secondary outcomes (9)
Progression of deep vein thrombosis (DVT)
Extension of a previously diagnosed DVT to a more proximal site
Measured: hospitalization in UTI, an average of 10 days
Prophylaxis/ treatment of venous thromboembolism (VTE)
Necessity of prophylaxis/ treatment of VTE and its possible modifications during the stay in Intensive Care Unit
Measured: hospitalization in UTI, an average of 10 days
Incidence of pulmonary embolism
Findings of pulmonary embolism at contrast-enhanced CT scan
Measured: hospitalization in UTI, an average of 10 days
Occurrence of major bleeding
According to the definition of the International Society of Thrombosis and Hemostasis
Measured: hospitalization in UTI, an average of 10 days
Occurrence of anemia
Reduction of hemoglobin >2 g/dL without evidence of active bleeding
Measured: hospitalization in UTI, an average of 10 days
Duration of ICU stay
Duration of ICU stay
Measured: hospitalization in UTI, an average of 10 days
Risk of death in ICU
Death
Measured: hospitalization in UTI, an average of 10 days
Risk of death within 3 months after hospital discharge
Death
Measured: Within 3 months after hospital discharge
Risk of new hospital admission within 3 months after hospital discharge
New hospital admission
Measured: Within 3 months after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start1 Jan 2021
- Primary completion30 Jun 2021
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ettore Marini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ettore Marini, University Of Perugia
- Investigators
- Leonella Pasqualini, MD, Principal investigator, University Of Perugia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019092
- Sponsor's protocol ID
- TVP_UTI_1
- Status last verified
- Aug 2021
- First submitted
- 5 Aug 2021
- Last updated
- 24 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Authors agree to share IPD after publication of results. Data will be access on request to the corresponding Author.
Publications
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.
PubMed 36044159
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Harms and Benefits of Systematic Screening for Deep Vein Thrombosis in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT05019092
- Acronym / sponsor ID
- TVP_UTI_1
- Conditions
- Deep Vein Thrombosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ettore MariniUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 24 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Screening | Experimental | Diagnostic Test: Ultrasound examination of lower limb veinsUltrasound (US) examination of lower limbs 48 hours after admission and again after 3-5 days (5-7 days after the admission) |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >18 years old
- Admission to the ICU
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound examination of lower limb veinsUltrasound 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. | Diagnostic test | Screening |
Primary outcome
Incidence of deep vein thrombosis
Time frame: hospitalization in UTI, an average of 10 days
Diagnosis of deep vein thrombosis
9 secondary outcomes
Progression of deep vein thrombosis (DVT)
Time frame: hospitalization in UTI, an average of 10 days
Prophylaxis/ treatment of venous thromboembolism (VTE)
Time frame: hospitalization in UTI, an average of 10 days
Incidence of pulmonary embolism
Time frame: hospitalization in UTI, an average of 10 days
Occurrence of major bleeding
Time frame: hospitalization in UTI, an average of 10 days
Occurrence of anemia
Time frame: hospitalization in UTI, an average of 10 days
Duration of ICU stay
Time frame: hospitalization in UTI, an average of 10 days
Risk of death in ICU
Time frame: hospitalization in UTI, an average of 10 days
Risk of death within 3 months after hospital discharge
Time frame: Within 3 months after hospital discharge
Risk of new hospital admission within 3 months after hospital discharge
Time frame: Within 3 months after hospital discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Derived from this study: PubMed 36044159Tini 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.
- Individual participant dataSharing planned: Yes. Authors agree to share IPD after publication of results. Data will be access on request to the corresponding Author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leonella Pasqualini, MD principal investigator
University Of Perugia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound examination of lower limb veins in people with Deep Vein Thrombosis, run by Ettore Marini at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of deep vein thrombosis (time frame: hospitalization in UTI, an average of 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05019092, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2021.