Ignite Creation Date:
2025-12-24 @ 4:48 PM
Ignite Modification Date:
2026-02-25 @ 4:12 AM
Study NCT ID:
NCT02978950
Status:
UNKNOWN
Last Update Posted:
2018-11-29
First Post:
2016-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SToP: Venous Thromboembolism Screening in the Trauma Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054556', 'term': 'Venous Thromboembolism'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D009104', 'term': 'Multiple Trauma'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D013927', 'term': 'Thrombosis'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-07-20', 'size': 690318, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2017-08-14T21:06', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-28', 'studyFirstSubmitDate': '2016-11-23', 'studyFirstSubmitQcDate': '2016-11-30', 'lastUpdatePostDateStruct': {'date': '2018-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Asymptomatic lower extremity DVT', 'timeFrame': 'during index hospitalization, up to 2 weeks', 'description': 'any DVT found in the lower extremity'}], 'secondaryOutcomes': [{'measure': 'Symptomatic DVT propagation from calf veins to proximal veins', 'timeFrame': '14 days from hospital discharge', 'description': 'calf vein clot that moves to popliteal vein or higher'}, {'measure': 'Symptomatic/fatal pulmonary embolism', 'timeFrame': '90 days from hospital discharge', 'description': 'any pulmonary embolism diagnosed by computed tomography angiogram'}, {'measure': 'Major and clinically relevant bleeding episodes', 'timeFrame': 'during index hospitalization, up to 2 weeks', 'description': 'as defined by the International Society of Thrombosis and Hemostasis'}, {'measure': 'Composite outcome of proximal DVT plus major and clinically relevant bleeding episodes', 'timeFrame': 'during index hospitalization, up to 2 weeks', 'description': 'additive outcome of above knee thrombosis plus major and clinically relevant bleeding'}, {'measure': 'All cause mortality', 'timeFrame': '90 days'}, {'measure': 'Symptomatic DVT', 'timeFrame': '90 days', 'description': 'any lower extremity thrombosis that causes clinical symptoms'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['duplex ultrasound', 'trauma', 'venous thromboembolism', 'prevention'], 'conditions': ['Venous Thromboembolism', 'Deep Vein Thrombosis', 'Trauma, Multiple']}, 'referencesModule': {'references': [{'pmid': '33560104', 'type': 'DERIVED', 'citation': 'Kay AB, Morris DS, Woller SC, Stevens SM, Bledsoe JR, Lloyd JF, Collingridge DS, Majercik S. Trauma patients at risk for venous thromboembolism who undergo routine duplex ultrasound screening experience fewer pulmonary emboli: A prospective randomized trial. J Trauma Acute Care Surg. 2021 May 1;90(5):787-796. doi: 10.1097/TA.0000000000003104.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective, randomized vanguard trial of trauma patients admitted to the trauma surgery service at Intermountain Medical Center who are deemed to be at high risk for venous thromboembolism. Once identified and enrolled, subjects will be randomized to receive bilateral lower extremity duplex ultrasound surveillance versus no surveillance. The study will compare the two groups with regard to deep vein thrombosis, pulmonary embolism, and major and clinically relevant bleeding episode rates, both during the index hospitalization and at 90 days post-discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Inpatient status on Intermountain Medical Center (IMC) trauma surgery service, admitted within 24 hours of injury.\n2. Age ≥18 at the time of injury\n3. Meets the definition of high-risk for VTE according to current IMC trauma service guidelines\n\nExclusion Criteria:\n\n1. Patient age \\<18 years at the time of admission to the hospital\n2. Pregnancy\n3. Prisoners\n4. Patients with a life expectancy of less than 30 days\n5. Patients with a known hypercoagulable state including:\n\n * Factor V Leiden\n * Protein C and S deficiencies\n * Dysfibrogenemia of any sort\n * Active cancer\n * Antiphospholipid antibody syndrome\n * History of DVT or PE within past 6 months\n * Myeloproliferative disorders\n6. Patients on therapeutic anticoagulation who do not have their agent held upon admission to the hospital.\n7. Patient elects to opt-out of the study'}, 'identificationModule': {'nctId': 'NCT02978950', 'acronym': 'SToP', 'briefTitle': 'SToP: Venous Thromboembolism Screening in the Trauma Population', 'organization': {'class': 'OTHER', 'fullName': 'Intermountain Health Care, Inc.'}, 'officialTitle': 'SToP: Venous Thromboembolism Screening in the Trauma Population', 'orgStudyIdInfo': {'id': '1050048'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Surveillance arm', 'description': 'Bilateral duplex ultrasound surveillance', 'interventionNames': ['Other: Duplex ultrasound surveillance']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No surveillance arm', 'description': 'no duplex ultrasound surveillance', 'interventionNames': ['Other: No ultrasound surveillance']}], 'interventions': [{'name': 'Duplex ultrasound surveillance', 'type': 'OTHER', 'description': 'bilateral lower extremity venous duplex', 'armGroupLabels': ['Surveillance arm']}, {'name': 'No ultrasound surveillance', 'type': 'OTHER', 'description': 'will have daily exam and history as per normal clinical routine', 'armGroupLabels': ['No surveillance arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84157', 'city': 'Murray', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Valerie Aston, MBA, RT', 'role': 'CONTACT', 'email': 'Valerie.Aston@imail.org', 'phone': '801-507-4606'}, {'name': 'Brent Armbruster', 'role': 'CONTACT', 'email': 'Brent.Armbruster@imail.org', 'phone': '801-507-4605'}, {'name': 'Annika Bickford, PA-C', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Joseph Bledsoe, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mark Stevens, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tom White, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Don VanBoerum, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Steve Granger, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Scott Stevens, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Scott Woller, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'C. Greg Elliott, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Intermountain Medical Center', 'geoPoint': {'lat': 40.66689, 'lon': -111.88799}}], 'centralContacts': [{'name': 'Brent Armbruster', 'role': 'CONTACT', 'email': 'brent.armbruster@imail.org', 'phone': '801-507-4605'}, {'name': 'Valerie Aston, MBA, RT', 'role': 'CONTACT', 'email': 'Valerie.Aston@imail.org', 'phone': '801-507-4606'}], 'overallOfficials': [{'name': 'Sarah Majercik, MD,MBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Intermountain Health Care, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Intermountain Health Care, Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}