Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2026-03-29 @ 12:28 AM
Study NCT ID:
NCT02396732
Status:
TERMINATED
Last Update Posted:
2019-11-19
First Post:
2015-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Aspirin and Enoxaparin for VTE in Trauma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054556', 'term': 'Venous Thromboembolism'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}, {'id': 'D017984', 'term': 'Enoxaparin'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kproctor@med.miami.edu', 'phone': '305-585-1178', 'title': 'Kenneth Proctor', 'organization': 'University of Miami'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 2 months', 'description': 'For purposes of this study we are only collecting and reporting the following adverse events: Acute Respiratory Syndrome, Altered Mental Status, Bacteremia, Pneumonia, Venous Thromboembolism, Bleeding Complications, Acute Kidney Injury, Urinary Tract Infection, Surgical Site Infection and Mortality.', 'eventGroups': [{'id': 'EG000', 'title': 'LMWH + ASA', 'description': 'Group will get both enoxaparin (standard of care) and aspirin (intervention) after consent up to Intensive Care Unit (ICU) discharge.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 1, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'LMWH Alone', 'description': 'Group will get only enoxaparin (standard of care) after consent up to Intensive Care Unit (ICU) discharge.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 1, 'seriousNumAtRisk': 17, 'deathsNumAffected': 1, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Altered Mental Status', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Venous Thromboembolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bacteremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Venous Thromboembolism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LMWH + ASA', 'description': 'Group will get both enoxaparin (standard of care) and aspirin (intervention) after consent up to Intensive Care Unit (ICU) discharge.'}, {'id': 'OG001', 'title': 'LMWH Alone', 'description': 'Group will get only enoxaparin (standard of care) after consent up to Intensive Care Unit (ICU) discharge.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 2 months of hospitalization', 'description': 'Incidence of VTE is defined as new cases reported of: 1. Deep Vein Thrombosis (DVT), symptomatic or asymptomatic as assessed via venous duplex ultrasonography, and 2. Pulmonary Embolism (PE), symptomatic or asymptomatic as assessed via chest computed tomography with angiography (CTA) or ventilation-perfusion (VQ) Scan', 'unitOfMeasure': 'incidents', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Hypercoagulability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LMWH + ASA', 'description': 'Group will get both enoxaparin (standard of care) and aspirin (intervention) after consent up to Intensive Care Unit (ICU) discharge.'}, {'id': 'OG001', 'title': 'LMWH Alone', 'description': 'Group will get only enoxaparin (standard of care) after consent up to Intensive Care Unit (ICU) discharge.'}], 'timeFrame': 'Baseline, up to 2 months hospitalization', 'description': 'Assessed via the combination of routine laboratory values (Prothrombin Time and Partial Thromboplastin Time) evaluated through weekly thromboelastography (TEG)', 'reportingStatus': 'POSTED', 'populationDescription': 'Data analysis was not completed for this outcome as samples were not collected as per protocol.'}, {'type': 'SECONDARY', 'title': 'Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LMWH + ASA', 'description': 'Group will get both enoxaparin (standard of care) and aspirin (intervention) after consent up to Intensive Care Unit (ICU) discharge.'}, {'id': 'OG001', 'title': 'LMWH Alone', 'description': 'Group will get only enoxaparin (standard of care) after consent up to Intensive Care Unit (ICU) discharge.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 2 months of hospitalization', 'description': 'Mortality will be reported as the number of participants with reported death upon hospital discharge', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LMWH + ASA', 'description': 'Group will get both enoxaparin (standard of care) and aspirin (intervention) after consent up to Intensive Care Unit (ICU) discharge.'}, {'id': 'FG001', 'title': 'LMWH Alone', 'description': 'Group will get only enoxaparin (standard of care) after consent up to Intensive Care Unit (ICU) discharge.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'LMWH + ASA', 'description': 'Group will get both enoxaparin (standard of care) and aspirin (intervention) after consent up to Intensive Care Unit (ICU) discharge.'}, {'id': 'BG001', 'title': 'LMWH Alone', 'description': 'Group will get only enoxaparin (standard of care) after consent up to Intensive Care Unit (ICU) discharge.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40', 'spread': '13', 'groupId': 'BG000'}, {'value': '40', 'spread': '16', 'groupId': 'BG001'}, {'value': '40', 'spread': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black or African American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic / Latino', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-03-22', 'size': 151921, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-10-31T12:23', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'whyStopped': 'Terminated due to futility and less subjects meeting entry criteria', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-31', 'studyFirstSubmitDate': '2015-03-12', 'resultsFirstSubmitDate': '2019-10-26', 'studyFirstSubmitQcDate': '2015-03-17', 'lastUpdatePostDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-31', 'studyFirstPostDateStruct': {'date': '2015-03-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Venous Thromboembolism', 'timeFrame': 'Up to 2 months of hospitalization', 'description': 'Incidence of VTE is defined as new cases reported of: 1. Deep Vein Thrombosis (DVT), symptomatic or asymptomatic as assessed via venous duplex ultrasonography, and 2. Pulmonary Embolism (PE), symptomatic or asymptomatic as assessed via chest computed tomography with angiography (CTA) or ventilation-perfusion (VQ) Scan'}], 'secondaryOutcomes': [{'measure': 'Change in Hypercoagulability', 'timeFrame': 'Baseline, up to 2 months hospitalization', 'description': 'Assessed via the combination of routine laboratory values (Prothrombin Time and Partial Thromboplastin Time) evaluated through weekly thromboelastography (TEG)'}, {'measure': 'Mortality', 'timeFrame': 'Up to 2 months of hospitalization', 'description': 'Mortality will be reported as the number of participants with reported death upon hospital discharge'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aspirin', 'Enoxaparin', 'Thromboprophylaxis', 'Trauma', 'Venous thromboembolism'], 'conditions': ['Venous Thromboembolism', 'Thromboprophylaxis', 'Trauma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if the addition of antiplatelet therapy (i.e. aspirin) to low-molecular-weight-heparin (i.e. enoxaparin) will decrease the incidence of venous thromboembolism (VTE) in high-risk critically injured patients. The investigators further aim to determine the safety and efficacy of dual thromboprophylaxis with aspirin and enoxaparin for decreasing the incidence of VTE after trauma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Blunt or penetrating trauma\n* Requires VTE thromboprophylaxis\n* High-risk for VTE\n\nExclusion Criteria:\n\n* Presence of VTE upon admission\n* Pregnant or nursing\n* Inability to give informed consent by patient or healthcare proxy\n* Contraindication to enoxaparin\n* Contraindication to aspirin\n* Epidural or subdural hematoma\n* Presence, or removal within the last 12 hours, of an epidural or spinal catheter, or recent (within the last 12 hours) epidural or spinal anesthesia/procedures'}, 'identificationModule': {'nctId': 'NCT02396732', 'briefTitle': 'Aspirin and Enoxaparin for VTE in Trauma', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'The Role Of Combined Therapy With Aspirin and Enoxaparin In Prevention Of Venous Thromboembolism In Trauma Patients: A Randomized-Controlled Trial', 'orgStudyIdInfo': {'id': '20140937'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low Molecular Weight Heparin (LMWH) + Aspirin (ASA)', 'description': 'Group will get both enoxaparin (standard of care) and aspirin (intervention) after consent up to Intensive Care Unit (ICU) discharge.', 'interventionNames': ['Drug: Aspirin', 'Drug: Enoxaparin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low Molecular Weight Heparin (LMWH) Alone', 'description': 'Group will get only enoxaparin (standard of care) after consent up to Intensive Care Unit (ICU) discharge.', 'interventionNames': ['Drug: Enoxaparin']}], 'interventions': [{'name': 'Aspirin', 'type': 'DRUG', 'description': 'Daily dose is 81 mg oral tablet', 'armGroupLabels': ['Low Molecular Weight Heparin (LMWH) + Aspirin (ASA)']}, {'name': 'Enoxaparin', 'type': 'DRUG', 'description': 'Daily dose is by subcutaneous injection and weight based at the discretion of the treating clinician.', 'armGroupLabels': ['Low Molecular Weight Heparin (LMWH) + Aspirin (ASA)', 'Low Molecular Weight Heparin (LMWH) Alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Ryder Trauma Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Kenneth Proctor, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Surgery', 'investigatorFullName': 'Kenneth Proctor', 'investigatorAffiliation': 'University of Miami'}}}}