Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2025-12-27 @ 10:51 AM
Study NCT ID:
NCT06246604
Status:
RECRUITING
Last Update Posted:
2024-02-07
First Post:
2023-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening for Deep Vein Thrombosis in Intensive Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020246', 'term': 'Venous Thrombosis'}], 'ancestors': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Enrolling centers are blinded to each others. Investigators are blinded to centers allocation.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multicenter trial, involving 2 intervention arms: screening and standard-of-care.\n\nCenters are randomly allocated to provide the screening or the standard-of-care.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-29', 'studyFirstSubmitDate': '2023-11-26', 'studyFirstSubmitQcDate': '2024-01-29', 'lastUpdatePostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Major bleeding', 'timeFrame': 'From admission to ICU until the date of death from any cause or transfer to other facility, assessed up to 30 days', 'description': 'Clinically relevant bleeding'}, {'measure': 'Anemization', 'timeFrame': 'From admission to ICU until the date of death from any cause or transfer to other facility, assessed up to 30 days', 'description': 'Hemoglobin reduction \\>2 g/dL or need for transfusion during the ICU stay'}, {'measure': 'Pulmonary embolism', 'timeFrame': 'From admission to ICU until the date of death from any cause or transfer to other facility, assessed up to 30 days', 'description': 'Pulmonary embolism diagnosed by chest CT'}], 'primaryOutcomes': [{'measure': 'Proximal deep vein thrombosis', 'timeFrame': 'Within 48-72 hours after admission to ICU', 'description': 'Deep vein thrombosis located above the popliteal area'}], 'secondaryOutcomes': [{'measure': 'Mortality in ICU', 'timeFrame': 'From admission to ICU until the date of death from any cause or transfer to other facility, assessed up to 30 days', 'description': 'Death rate during the hospitalization in ICU'}, {'measure': 'In-hospital mortality', 'timeFrame': 'From admission to ICU until the date of death from any cause or discharge, assessed up to 30 days', 'description': 'Death rate during the overall hospital stay'}, {'measure': '90-day mortality', 'timeFrame': 'Within 90 days after the admission of the ICU', 'description': 'Death rate within 90 days after the admission to the ICU'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Deep Vein Thrombosis']}, 'referencesModule': {'references': [{'pmid': '35830171', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '36044159', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nAim 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.\n\nExpected 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* any patient admitted to ICU with a length-of-stay in ICU \\>96 hours\n\nExclusion Criteria:\n\n* pregnancy\n* SARS-CoV-2 infection\n* established DVT or pulmonary embolism at admission\n* established coagulation disorder\n* presence of inferior vena cava filter at the admission\n* admission from the ICU of another hospital'}, 'identificationModule': {'nctId': 'NCT06246604', 'acronym': 'DVT_ICU2', 'briefTitle': 'Screening for Deep Vein Thrombosis in Intensive Care', 'organization': {'class': 'OTHER', 'fullName': 'University Of Perugia'}, 'officialTitle': 'Ultrasound Screening for Asymptomatic Deep Vein Thrombosis in Critically Ill Patient: a Multicenter Trial', 'orgStudyIdInfo': {'id': 'DVT_ICU2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Screening', 'description': '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:\n\n* if the pharmacological thromboprophylaxis is NOT possible, ultrasound is repeated after 48-96 hours;\n* if the pharmacological thromboprophylaxis is possible, re-evaluation is warrant only in case of clinical changes.\n\nIn case of positive ultrasound:\n\n* if the DVT is proximal, it must be treated according to guidelines. Re-evaluation is warranted only in case of clinical changes;\n* 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;\n* if the DVT is distal and a full or intermediate anti-thrombotic treatment is NOT possible, the ultrasound is repeated after 48-96 hours.', 'interventionNames': ['Diagnostic Test: Ultrasound screening for lower limbs DVT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard-of-care', 'description': 'Ultrasound examination are performed according to clinical risk of DVT', 'interventionNames': ['Diagnostic Test: Standard-of-care']}], 'interventions': [{'name': 'Ultrasound screening for lower limbs DVT', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['Screening']}, {'name': 'Standard-of-care', 'type': 'DIAGNOSTIC_TEST', 'description': 'Ultrasound examination of lower limbs is performed according to clinical risk of DVT', 'armGroupLabels': ['Standard-of-care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06012', 'city': 'Città di Castello', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Lucia Norgiolini, MD', 'role': 'CONTACT', 'email': 'lucia.norgiolini@uslumbria1.it', 'phone': '+39 075 85091'}], 'facility': "Azienda Sanitaria Locale N.1 dell'Umbria", 'geoPoint': {'lat': 43.46556, 'lon': 12.2375}}, {'zip': '06034', 'city': 'Foligno', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Matteo Vissani, MD', 'role': 'CONTACT', 'email': 'matteo.vissani@uslumbria2.it', 'phone': '+39 0742 3391'}], 'facility': "Azienda Sanitaria Locale N.2 dell'Umbria", 'geoPoint': {'lat': 42.95488, 'lon': 12.70268}}, {'zip': '06024', 'city': 'Gubbio', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Pierluigi Piergentili, MD', 'role': 'CONTACT', 'email': 'pierluigi.piergentili@uslumbria1.it', 'phone': '+390759270801'}], 'facility': "Azienda Sanitaria Locale N.1 dell'Umbria", 'geoPoint': {'lat': 43.34996, 'lon': 12.57309}}, {'zip': '06123', 'city': 'Perugia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Edoardo De Robertis, MD', 'role': 'CONTACT', 'email': 'edoardo.derobertis@unipg.it', 'phone': '+390755786428'}], 'facility': 'Azienda Ospedaliera di Perugia', 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}, {'zip': '05100', 'city': 'Terni', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Rita Commissari, MD', 'role': 'CONTACT', 'email': 'r.commissari@aospterni.it', 'phone': '+3907442051'}], 'facility': 'Azienda Ospedaliera di Terni', 'geoPoint': {'lat': 42.56335, 'lon': 12.64329}}], 'centralContacts': [{'name': 'Leonella Pasqualini, MD', 'role': 'CONTACT', 'email': 'leonella.pasqualini@unipg.it', 'phone': '+390755784030'}], 'overallOfficials': [{'name': 'Leonella Pasqualini, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Of Perugia'}]}, 'ipdSharingStatementModule': {'timeFrame': '2025-2035', 'ipdSharing': 'YES', 'description': 'IPD are available on motivated request to the principal investigator', 'accessCriteria': 'motivated request to the principal investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Of Perugia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Azienda Ospedaliera di Perugia', 'class': 'OTHER'}, {'name': 'Azienda Ospedaliera di Terni', 'class': 'UNKNOWN'}, {'name': "Azienda Sanitaria Locale N.1 dell'Umbria", 'class': 'OTHER'}, {'name': 'USL Umbria 2', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': 'Stefano Ministrini', 'investigatorAffiliation': 'University Of Perugia'}}}}