Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-28 @ 7:50 AM
Study NCT ID:
NCT05019092
Status:
UNKNOWN
Last Update Posted:
2021-08-24
First Post:
2021-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Systematic Screening for Deep Vein Thrombosis in Critically Ill Patients
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-19', 'studyFirstSubmitDate': '2021-08-05', 'studyFirstSubmitQcDate': '2021-08-19', 'lastUpdatePostDateStruct': {'date': '2021-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of deep vein thrombosis', 'timeFrame': 'hospitalization in UTI, an average of 10 days', 'description': 'Diagnosis of deep vein thrombosis'}], 'secondaryOutcomes': [{'measure': 'Progression of deep vein thrombosis (DVT)', 'timeFrame': 'hospitalization in UTI, an average of 10 days', 'description': 'Extension of a previously diagnosed DVT to a more proximal site'}, {'measure': 'Prophylaxis/ treatment of venous thromboembolism (VTE)', 'timeFrame': 'hospitalization in UTI, an average of 10 days', 'description': 'Necessity of prophylaxis/ treatment of VTE and its possible modifications during the stay in Intensive Care Unit'}, {'measure': 'Incidence of pulmonary embolism', 'timeFrame': 'hospitalization in UTI, an average of 10 days', 'description': 'Findings of pulmonary embolism at contrast-enhanced CT scan'}, {'measure': 'Occurrence of major bleeding', 'timeFrame': 'hospitalization in UTI, an average of 10 days', 'description': 'According to the definition of the International Society of Thrombosis and Hemostasis'}, {'measure': 'Occurrence of anemia', 'timeFrame': 'hospitalization in UTI, an average of 10 days', 'description': 'Reduction of hemoglobin \\>2 g/dL without evidence of active bleeding'}, {'measure': 'Duration of ICU stay', 'timeFrame': 'hospitalization in UTI, an average of 10 days', 'description': 'Duration of ICU stay'}, {'measure': 'Risk of death in ICU', 'timeFrame': 'hospitalization in UTI, an average of 10 days', 'description': 'Death'}, {'measure': 'Risk of death within 3 months after hospital discharge', 'timeFrame': 'Within 3 months after hospital discharge', 'description': 'Death'}, {'measure': 'Risk of new hospital admission within 3 months after hospital discharge', 'timeFrame': 'Within 3 months after hospital discharge', 'description': 'New hospital admission'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Deep Vein Thrombosis']}, 'referencesModule': {'references': [{'pmid': '36044159', 'type': 'DERIVED', '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.\n\nAim of the study: investigating potential harms and benefits of a protocol for systematic screening of DVT in critically ill patients, admitted to an ICU.\n\nExpected 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years old\n* Admission to the ICU\n\nExclusion Criteria:\n\n* duration of stay in ICU \\<5 days\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/discharge to the ICU of another hospital'}, 'identificationModule': {'nctId': 'NCT05019092', 'briefTitle': 'Systematic Screening for Deep Vein Thrombosis in Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Of Perugia'}, 'officialTitle': 'Potential Harms and Benefits of Systematic Screening for Deep Vein Thrombosis in Critically Ill Patients', 'orgStudyIdInfo': {'id': 'TVP_UTI_1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Screening', 'description': 'Ultrasound (US) examination of lower limbs 48 hours after admission and again after 3-5 days (5-7 days after the admission)', 'interventionNames': ['Diagnostic Test: Ultrasound examination of lower limb veins']}, {'type': 'NO_INTERVENTION', 'label': 'Control', '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.'}], 'interventions': [{'name': 'Ultrasound examination of lower limb veins', 'type': 'DIAGNOSTIC_TEST', '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.', 'armGroupLabels': ['Screening']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Perugia', 'country': 'Italy', 'facility': 'Medicine Interna, Angiologia e Malattie da arteriosclerosi', 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}], 'overallOfficials': [{'name': 'Leonella Pasqualini, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Of Perugia'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'After publication of results', 'ipdSharing': 'YES', 'description': 'Authors agree to share IPD after publication of results. Data will be access on request to the corresponding Author.', 'accessCriteria': 'Available on request, by the corresponding author'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ettore Marini', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ettore Marini', 'investigatorAffiliation': 'University Of Perugia'}}}}