Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-25 @ 7:33 PM
Study NCT ID:
NCT01300832
Status:
COMPLETED
Last Update Posted:
2024-07-23
First Post:
2011-02-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Incidence of Perioperative Deep Venous Thromboses of the Lower Extremities
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 271}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-19', 'studyFirstSubmitDate': '2011-02-18', 'studyFirstSubmitQcDate': '2011-02-18', 'lastUpdatePostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of preoperative DVTs', 'timeFrame': 'Day of surgery'}, {'measure': 'Incidence of post-operative DVTs', 'timeFrame': 'Within 48 hours of surgery'}], 'secondaryOutcomes': [{'measure': 'Risk factors associated with the development of perioperative DVTs', 'timeFrame': 'Within 180 days of surgery'}, {'measure': 'Distribution and laterality', 'timeFrame': 'Within 180 days of surgery', 'description': 'Level and laterality of clots that develop and association of these with risk factors'}, {'measure': 'Risks associated with perioperative DVTs', 'timeFrame': 'Within 180 days of surgery', 'description': 'Association of clinical pulmonary emboli and/or cardiac arrests, cerebral vascular events, or other causes of death or significant morbidities (e.g., post-op pneumonias or other infections)perioperatively with DVTs'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Surgery', 'Deep Vein Thrombosis', 'Preoperative'], 'conditions': ['Perioperative DVTs']}, 'descriptionModule': {'briefSummary': "The study's hypothesis is that there are some patients who come for surgery who have asymptomatic clots in their lower extremities upon their arrival to the hospital for their surgical admission. We will be performing duplex studies of the subjects' legs before their surgery to determine how often clots are present. We will also perform duplex scans of the legs after the subjects' surgeries to determine what factors (surgical, anesthetic, co-morbidities)are correlated with the development of DVTs."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18+ and consentable\n\nExclusion Criteria:\n\n* Anticoagulation therapy or known DVT'}, 'identificationModule': {'nctId': 'NCT01300832', 'briefTitle': 'The Incidence of Perioperative Deep Venous Thromboses of the Lower Extremities', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Chicago'}, 'officialTitle': 'The Incidence of Perioperative Deep Venous Thromboses of the Lower Extremities', 'orgStudyIdInfo': {'id': '10-589-A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Duplex scan', 'description': 'Subjects undergo preoperative and post-operative duplex scanning of the lower extremities', 'interventionNames': ['Procedure: Duplex scan of lower extremities']}], 'interventions': [{'name': 'Duplex scan of lower extremities', 'type': 'PROCEDURE', 'description': 'Lower extremities will be duplex scanned pre and post-operatively', 'armGroupLabels': ['Duplex scan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Hospitals', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'David Glick, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Illinois at Chicago, Department of Anesthesiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}