Deep Vein ThrombosisDVT_ICU2NCT06246604
Screening for Deep Vein Thrombosis in Intensive Care
A study testing Ultrasound screening for lower limbs DVT and Standard-of-care in people with Deep Vein Thrombosis, run by University Of Perugia at 5 sites 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 screening for lower limbs DVT and Standard-of-care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,300 participants
- Where
- 5 sitesItaly
- Study dates
- 1 Nov 2023to 31 Dec 2024
- 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
- any patient admitted to ICU with a length-of-stay in ICU >96 hours
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Italy5 sites, 5 recruiting
- Recruiting
Azienda Sanitaria Locale N.1 dell'Umbria
Città di Castello, 06012
Lucia Norgiolini, MD, +39 075 85091, lucia.norgiolini@uslumbria1.it
- Recruiting
Azienda Sanitaria Locale N.2 dell'Umbria
Foligno, 06034
Matteo Vissani, MD, +39 0742 3391, matteo.vissani@uslumbria2.it
- Recruiting
Azienda Sanitaria Locale N.1 dell'Umbria
Gubbio, 06024
Pierluigi Piergentili, MD, +390759270801, pierluigi.piergentili@uslumbria1.it
- Recruiting
Azienda Ospedaliera di Perugia
Perugia, 06123
Edoardo De Robertis, MD, +390755786428, edoardo.derobertis@unipg.it
- Recruiting
Azienda Ospedaliera di Terni
Terni, 05100
Rita Commissari, MD, +3907442051, r.commissari@aospterni.it
About this study
Official title: Ultrasound Screening for Asymptomatic Deep Vein Thrombosis in Critically Ill Patient: a Multicenter Trial
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
- Being tested
- Ultrasound screening for lower limbs DVT, Standard-of-care
- 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 screening for lower limbs DVTDiagnostic 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-careDiagnostic test
Ultrasound examination of lower limbs is performed according to clinical risk of DVT
| Study group | Role | What they receive |
|---|---|---|
| Screening | Experimental | 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. Receives: Diagnostic Test: Ultrasound screening for lower limbs DVT |
| Standard-of-care | Active comparator | Ultrasound examination are performed according to clinical risk of DVT Receives: Diagnostic Test: Standard-of-care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proximal deep vein thrombosis
Deep vein thrombosis located above the popliteal area
Measured: Within 48-72 hours after admission to ICU
Secondary outcomes (3)
Mortality in ICU
Death rate during the hospitalization in ICU
Measured: From admission to ICU until the date of death from any cause or transfer to other facility, assessed up to 30 days
In-hospital mortality
Death rate during the overall hospital stay
Measured: From admission to ICU until the date of death from any cause or discharge, assessed up to 30 days
90-day mortality
Death rate within 90 days after the admission to the ICU
Measured: Within 90 days after the admission of the ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start1 Nov 2023
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter trial, involving 2 intervention arms: screening and standard-of-care. Centers are randomly allocated to provide the screening or the standard-of-care.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Of Perugia
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera di Perugia, S. Maria Hospital, Terni, Azienda Sanitaria Locale N.1 dell'Umbria, USL Umbria 2
- Responsible party
- Principal investigator, Stefano Ministrini, University Of Perugia
- Investigators
- Leonella Pasqualini, MD, Study director, University Of Perugia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246604
- Sponsor's protocol ID
- DVT_ICU2
- Acronym
- DVT_ICU2
- Status last verified
- Jan 2024
- First submitted
- 26 Nov 2023
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD are available on motivated request to the principal investigator
Publications
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.
PubMed 35830171Tini 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 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Screening for Asymptomatic Deep Vein Thrombosis in Critically Ill Patient: a Multicenter Trial
- ClinicalTrials.gov ID
- NCT06246604
- Acronym / sponsor ID
- DVT_ICU2 / DVT_ICU2
- Conditions
- Deep Vein Thrombosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- University Of PerugiaUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera di Perugia, S. Maria Hospital, Terni, Azienda Sanitaria Locale N.1 dell'Umbria, USL Umbria 2
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 Feb 2024 (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. 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicenter trial, involving 2 intervention arms: screening and standard-of-care. Centers are randomly allocated to provide the screening or the standard-of-care.
| Arm | Type | Receives |
|---|---|---|
| Screening | Experimental | Diagnostic Test: Ultrasound screening for lower limbs DVTPatients 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. |
| Standard-of-care | Active comparator | Diagnostic Test: Standard-of-careUltrasound examination are performed according to clinical risk of DVT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- any patient admitted to ICU with a length-of-stay in ICU >96 hours
Key exclusion criteria (6 listed)
- pregnancy
- 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 screening for lower limbs DVTUsing 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. | Diagnostic test | Screening |
| Standard-of-careUltrasound examination of lower limbs is performed according to clinical risk of DVT | Diagnostic test | Standard-of-care |
Primary outcome
Proximal deep vein thrombosis
Time frame: Within 48-72 hours after admission to ICU
Deep vein thrombosis located above the popliteal area
3 secondary outcomes
Mortality in ICU
Time frame: From admission to ICU until the date of death from any cause or transfer to other facility, assessed up to 30 days
In-hospital mortality
Time frame: From admission to ICU until the date of death from any cause or discharge, assessed up to 30 days
90-day mortality
Time frame: Within 90 days after the admission of the ICU
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Background: PubMed 35830171Bikdeli 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.
- Results publication: 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. IPD are available on motivated request to the principal investigator
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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 study director
University Of Perugia
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound screening for lower limbs DVT and Standard-of-care in people with Deep Vein Thrombosis, run by University Of Perugia at 5 sites 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 1 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 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Contact Leonella Pasqualini, MD (+390755784030, leonella.pasqualini@unipg.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proximal deep vein thrombosis (time frame: Within 48-72 hours after admission to ICU). 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 NCT06246604, which also lists 2 linked publications.
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 7 Feb 2024.