Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-25 @ 6:16 PM
Study NCT ID:
NCT01045759
Status:
TERMINATED
Last Update Posted:
2016-09-30
First Post:
2010-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Point of Care Ultrasound (US) Versus Detailed Radiology US for Deep Vein Thrombosis (DVT)
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'whyStopped': 'Investigator left the institution', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-29', 'studyFirstSubmitDate': '2010-01-07', 'studyFirstSubmitQcDate': '2010-01-07', 'lastUpdatePostDateStruct': {'date': '2016-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The agreement between physician performed ultrasound and formal duplex ultrasonography for detection of proximal deep vein thrombosis.', 'timeFrame': '48 hours window from detailed US'}], 'secondaryOutcomes': [{'measure': 'Subgroup analysis: location of thrombus (proximal or distal)', 'timeFrame': '48 hours window from detailed US'}, {'measure': 'Subgroup analysis: number of days in the hospital prior to exam', 'timeFrame': '48 hours window from detailed US'}, {'measure': 'Subgroup analysis: body mass index (BMI)', 'timeFrame': '48 hours window from detailed US'}, {'measure': 'Subgroup analysis: weight gain from admission to the time of the exam', 'timeFrame': '48 hours window from detailed US'}, {'measure': 'Subgroup analysis: training level of examiner', 'timeFrame': '48 hours window from detailed US'}, {'measure': 'Subgroup analysis: difficulty of exam', 'timeFrame': '48 hours window from detailed US'}, {'measure': 'Subgroup analysis: specific examiner', 'timeFrame': '48 hours window from detailed US'}, {'measure': 'Subgroup analysis: presence or absence of calf vein thrombosis', 'timeFrame': 'at study conclusion'}, {'measure': 'Subgroup analysis: presence or absence of pulmonary embolism', 'timeFrame': 'at study conclusion'}, {'measure': 'Subgroup analysis: DVT location', 'timeFrame': 'at study conclusion'}, {'measure': 'Subgroup analysis: calf vein thrombosis', 'timeFrame': 'at study conclusion'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['VENOUS THROMBOSIS', 'ultrasonography', 'intensive care unit'], 'conditions': ['DEEP VEIN THROMBOSIS']}, 'descriptionModule': {'briefSummary': 'We propose an observational study to assess the ability of intensivists to evaluate for deep vein thrombosis using 2 point compression ultrasonography.', 'detailedDescription': 'Deep vein thrombosis is a common problem in the intensive care unit and diagnosis is often delayed due to limited availability of a formal duplex ultrasound. Physician performed 2 point compression ultrasonography has been shown to have reasonable accuracy when performed in the emergency department and outpatient setting, but has not been studied on patients in the intensive care unit. We propose an observational study to assess the ability of intensivists to evaluate for deep vein thrombosis using 2 point compression ultrasonography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of adult patients admitted to the intensive care units at University hospital who have a duplex ultrasound of the lower extremities for detection of deep vein thrombosis ordered by the primary team.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female adults at least 18 years of age\n* Duplex ultrasonography ordered by treating team\n* Admission to the Medical, Cardiac, Burn, or Surgical intensive care units\n\nExclusion Criteria:\n\n* Patients less than 18 years of age\n* Patients with a known current DVT\n* patients on whom the exam cannot be performed (above the knee amputation, severe cellulitis of groin or popliteal fossa, hip or knee fracture)'}, 'identificationModule': {'nctId': 'NCT01045759', 'briefTitle': 'Point of Care Ultrasound (US) Versus Detailed Radiology US for Deep Vein Thrombosis (DVT)', 'organization': {'class': 'OTHER', 'fullName': 'University of Missouri-Columbia'}, 'officialTitle': 'Intensivist Performed Limited B Mode Compression Ultrasound for Diagnosis of Deep Vein Thrombosis in the Intensive Care Unit', 'orgStudyIdInfo': {'id': '1143800'}}, 'contactsLocationsModule': {'locations': [{'zip': '65212', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of missouri healthcare', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}], 'overallOfficials': [{'name': 'Casey Stahlheber, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Missouri-Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Missouri-Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}