Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-30 @ 8:32 PM
Study NCT ID:
NCT00358735
Status:
COMPLETED
Last Update Posted:
2014-10-30
First Post:
2006-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Deep Vein Thrombosis (DVT) Prevention in Total Hip Arthroplasty: Continuous Enhanced Circulation Therapy (CECT) Versus Low Molecular Weight Heparin (LMWH)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D011655', 'term': 'Pulmonary Embolism'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017984', 'term': 'Enoxaparin'}], 'ancestors': [{'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': 'Jbarak@mcsmed.com', 'phone': '972-4-6266630', 'title': 'Clifford W Colwell, M.D Scripps Clinic', 'phoneExt': '412', 'organization': 'Medical Compression Systems'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'SAE data were collected Up to 3 months post-op', 'description': 'SAE did not include VTE events(DVT and PE) and Major bleeding complications as these are outcome measures', 'eventGroups': [{'id': 'EG000', 'title': 'ActiveCare+SFT (Experimental)', 'description': 'The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).', 'otherNumAtRisk': 198, 'otherNumAffected': 89, 'seriousNumAtRisk': 198, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'LMWH (Enoxaparin) (Active Comparator)', 'description': 'Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).', 'otherNumAtRisk': 194, 'otherNumAffected': 102, 'seriousNumAtRisk': 194, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Minor Bleeding', 'notes': 'Minor bleeding was any bleeding that was not major bleeding (e.g., increased wound drainage reported by the surgeon or a drop in the hemoglobin level not requiring transfusion or prolonged hospitalization).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 74, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 78, 'numAffected': 78}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 22, 'numAffected': 22}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Cardiac Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 194, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 194, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever due to aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 194, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Parkinson (new event)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 194, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stress fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 194, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'supraventricular cardiac arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 194, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombocytopenia (HIT?)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 194, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Events of Deep Vein Thrombosis (DVT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}, {'units': 'Number of Hips Analyzed', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ActiveCare+SFT (Experimental)', 'description': 'The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).'}, {'id': 'OG001', 'title': 'LMWH (Enoxaparin) (Active Comparator)', 'description': 'Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).'}], 'classes': [{'title': 'Total DVT', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Distal DVT', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Proximal DVT', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '10-12 days post-op; and from day of surgery and up to 3 months if symptomatic', 'description': '10-12 days post-op: All of the patients underwent Routine bilateral compression Doppler.\n\nDay of surgery and up to 3 months post-op: Suspected clinical signs and symptoms DVT events were confirmed by standard diagnostic objective methods', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Hips Analyzed', 'denomUnitsSelected': 'Participants'}, {'type': 'PRIMARY', 'title': 'Clinical PE (Pulmonary Embolism) Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}, {'units': 'Number of Hips Analyzed', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ActiveCare+SFT (Experimental)', 'description': 'The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).'}, {'id': 'OG001', 'title': 'LMWH (Enoxaparin) (Active Comparator)', 'description': 'Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day of surgery and up to 3 months', 'description': 'Clinical PE events PE (Pulmonary Embolism) events were confirmed by spiral CT', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Hips Analyzed', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Major Bleeding Complication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}, {'units': 'Number of Hips Analyzed', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ActiveCare+SFT (Experimental)', 'description': 'The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).'}, {'id': 'OG001', 'title': 'LMWH (Enoxaparin) (Active Comparator)', 'description': 'Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0004', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 30 days', 'description': 'Major bleeding is defined as bleeding that requires rehospitalization or prolonged hospitalization, requires any intervention such as surgery or hematoma aspiration to prevent permanent impairment or damage, endangered critical organs, is life threatening or causes death. Data collected included bleeding index, a decrease in hemoglobin greater than/equal to 20 g/L, and number of units of blood transfused.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Hips Analyzed', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': "OutPatient Patients' Compliance", 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ActiveCare+SFT (Experimental)', 'description': 'The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).'}], 'classes': [{'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10-12 days post-op', 'description': "Total usage time with the pneumatic device (patient's compliance) was recorded using the ActiveCare+SFT device internal timer.\n\nThe compliance was calculate as total actual operation time (for the entire arm/group) divided by the total time passes since the initiation of home treatment (for the entire arm/group).\n\nThe compliance is expressed as percentages.", 'unitOfMeasure': 'percentage of usage time', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Events of Clinical Sign and Symptoms of VTE (DVT and/or PE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}, {'units': 'Number of Hips Analyzed', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ActiveCare+SFT (Experimental)', 'description': 'The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).'}, {'id': 'OG001', 'title': 'LMWH (Enoxaparin) (Active Comparator)', 'description': 'Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.953', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day of surgery and up to 3 months', 'description': 'Events of clinical Sign and symptoms of VTE (DVT and/or PE), confirmed by standard objective diagnostic methods', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Hips Analyzed', 'denomUnitsSelected': 'Participants'}, {'type': 'POST_HOC', 'title': 'Total Number of Blood Transfusion Units', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}, {'units': 'Number of Hips Analyzed', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ActiveCare+SFT (Experimental)', 'description': 'The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).'}, {'id': 'OG001', 'title': 'LMWH (Enoxaparin) (Active Comparator)', 'description': 'Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).'}], 'classes': [{'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.050', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Between the immediate postoperative measurement and discharge', 'description': 'Number of blood units used (Autologous units and allogeneic units) (blood units during surgery not included)', 'unitOfMeasure': 'Units', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Hips Analyzed', 'denomUnitsSelected': 'Participants'}, {'type': 'POST_HOC', 'title': 'Allogeneic Blood Transfusion Units', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ActiveCare+SFT (Experimental)', 'description': 'The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).'}, {'id': 'OG001', 'title': 'LMWH (Enoxaparin) (Active Comparator)', 'description': 'Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.13', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '0.32', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.010', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Up to 30 days', 'description': 'Allogeneic blood transfusion per patient in specific treatment Group', 'unitOfMeasure': 'Avg. Unit per patient in arm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Autologous Blood Transfusion Units', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ActiveCare+SFT (Experimental)', 'description': 'The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).'}, {'id': 'OG001', 'title': 'LMWH (Enoxaparin) (Active Comparator)', 'description': 'Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.28', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.52', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.507', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Up to 30 days', 'description': 'Autologous blood transfusion per patient in specific treatment Group', 'unitOfMeasure': 'Avg. Unit per patient in arm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Bleeding Index ≥ 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ActiveCare+SFT (Experimental)', 'description': 'The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).'}, {'id': 'OG001', 'title': 'LMWH (Enoxaparin) (Active Comparator)', 'description': 'Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.052', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Surgery till discharge', 'description': 'Bleeding index was defined as the number of units of whole blood or packed red blood cells transfused plus the difference between the first hemoglobin value after surgery and the value prior to discharge', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Changes in Hemoglobin Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ActiveCare+SFT (Experimental)', 'description': 'The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).'}, {'id': 'OG001', 'title': 'LMWH (Enoxaparin) (Active Comparator)', 'description': 'Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '9', 'spread': '1.47', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.798', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'After surgery untill discharge', 'description': 'Changes in Hemoglobin levels', 'unitOfMeasure': 'mean change (g/l)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Composite Outcome of Major Bleeding + VTE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ActiveCare+SFT (Experimental)', 'description': 'The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).'}, {'id': 'OG001', 'title': 'LMWH (Enoxaparin) (Active Comparator)', 'description': 'Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.036', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day of surgery and up to 3 months', 'description': 'Major bleeding + DVT events + PE Events', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ActiveCare+SFT (Experimental)', 'description': 'The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).'}, {'id': 'OG001', 'title': 'LMWH (Enoxaparin) (Active Comparator)', 'description': 'Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'SAE data were collected Up to 3 months post-op', 'description': 'Serious Adverse Events (SAE) is any event that prolongs hospitalization or requires re-hospitalization, that requires intervention to prevent permanent impairment or damage, that causes permanent disability, or that is life threatening.\n\nSAE did not include Venous thrombolembolism (VTE) events (DVT and PE) and Major bleeding complications as these are outcome measures', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "In-Patients' Compliance", 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ActiveCare+SFT (Experimental)', 'description': 'The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).'}], 'classes': [{'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Surgery till discharge', 'description': "Total usage time with the pneumatic device (patient's compliance) was recorded using the ActiveCare+SFT device internal timer.\n\nThe compliance was calculate as total actual operation time (for the entire arm/group) divided by the total time passes since the initiation of treatment at hospital (for the entire arm/group).\n\nThe compliance is expressed as percentages.", 'unitOfMeasure': 'percentage of usage time', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ActiveCare+SFT (Experimental)', 'description': 'The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).'}, {'id': 'FG001', 'title': 'LMWH (Enoxaparin) (Active Comparator)', 'description': 'Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '204'}, {'groupId': 'FG001', 'numSubjects': '207'}]}, {'type': 'Completed Safety', 'achievements': [{'groupId': 'FG000', 'numSubjects': '198'}, {'groupId': 'FG001', 'numSubjects': '194'}]}, {'type': 'Not Completed Safety', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Efficacy', 'groupId': 'FG000', 'numSubjects': '196'}, {'comment': 'Efficacy', 'groupId': 'FG001', 'numSubjects': '190'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '17'}]}]}], 'recruitmentDetails': 'Multi-center study. Recruitment began June 2006 and ended September 2008', 'preAssignmentDetails': 'Per protocol:. The pre-randomization evaluation (within 3 days of surgery, may be completed on admission) includes the following:\n\n* Review of inclusion/exclusion criteria (including evaluation for clinical signs and symptoms of DVT or PE)\n* Demographic parameters\n* Medical history'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'BG000'}, {'value': '194', 'groupId': 'BG001'}, {'value': '392', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ActiveCare+SFT (Experimental)', 'description': 'The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).'}, {'id': 'BG001', 'title': 'LMWH (Enoxaparin) (Active Comparator)', 'description': 'Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000', 'lowerLimit': '20', 'upperLimit': '84'}, {'value': '62', 'groupId': 'BG001', 'lowerLimit': '32', 'upperLimit': '88'}, {'value': '62.5', 'groupId': 'BG002', 'lowerLimit': '20', 'upperLimit': '88'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '214', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'body-mass index (Kg/m2)', 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000', 'lowerLimit': '17', 'upperLimit': '43'}, {'value': '29', 'groupId': 'BG001', 'lowerLimit': '16', 'upperLimit': '49'}, {'value': '28.5', 'groupId': 'BG002', 'lowerLimit': '16', 'upperLimit': '49'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg/m^2', 'dispersionType': 'FULL_RANGE'}, {'title': 'Diagnosis of osteoarthritis (n)', 'classes': [{'title': 'Diagnosis', 'categories': [{'measurements': [{'value': '186', 'groupId': 'BG000'}, {'value': '184', 'groupId': 'BG001'}, {'value': '370', 'groupId': 'BG002'}]}]}, {'title': 'No Diagnosis', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Duration of surgery (minutes)', 'classes': [{'categories': [{'measurements': [{'value': '91', 'groupId': 'BG000', 'lowerLimit': '44', 'upperLimit': '168'}, {'value': '96', 'groupId': 'BG001', 'lowerLimit': '41', 'upperLimit': '190'}, {'value': '93.5', 'groupId': 'BG002', 'lowerLimit': '41', 'upperLimit': '190'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Minutes', 'dispersionType': 'FULL_RANGE'}, {'title': 'length of hospital stay (days)', 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'groupId': 'BG000', 'lowerLimit': '2', 'upperLimit': '8'}, {'value': '3.2', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '10'}, {'value': '3.2', 'groupId': 'BG002', 'lowerLimit': '2', 'upperLimit': '10'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 411}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-21', 'studyFirstSubmitDate': '2006-07-30', 'resultsFirstSubmitDate': '2014-09-14', 'studyFirstSubmitQcDate': '2006-07-31', 'lastUpdatePostDateStruct': {'date': '2014-10-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-10-19', 'studyFirstPostDateStruct': {'date': '2006-08-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Events of Deep Vein Thrombosis (DVT)', 'timeFrame': '10-12 days post-op; and from day of surgery and up to 3 months if symptomatic', 'description': '10-12 days post-op: All of the patients underwent Routine bilateral compression Doppler.\n\nDay of surgery and up to 3 months post-op: Suspected clinical signs and symptoms DVT events were confirmed by standard diagnostic objective methods'}, {'measure': 'Clinical PE (Pulmonary Embolism) Events', 'timeFrame': 'Day of surgery and up to 3 months', 'description': 'Clinical PE events PE (Pulmonary Embolism) events were confirmed by spiral CT'}], 'secondaryOutcomes': [{'measure': 'Major Bleeding Complication', 'timeFrame': 'Up to 30 days', 'description': 'Major bleeding is defined as bleeding that requires rehospitalization or prolonged hospitalization, requires any intervention such as surgery or hematoma aspiration to prevent permanent impairment or damage, endangered critical organs, is life threatening or causes death. Data collected included bleeding index, a decrease in hemoglobin greater than/equal to 20 g/L, and number of units of blood transfused.'}, {'measure': "OutPatient Patients' Compliance", 'timeFrame': '10-12 days post-op', 'description': "Total usage time with the pneumatic device (patient's compliance) was recorded using the ActiveCare+SFT device internal timer.\n\nThe compliance was calculate as total actual operation time (for the entire arm/group) divided by the total time passes since the initiation of home treatment (for the entire arm/group).\n\nThe compliance is expressed as percentages."}, {'measure': 'Serious Adverse Events', 'timeFrame': 'SAE data were collected Up to 3 months post-op', 'description': 'Serious Adverse Events (SAE) is any event that prolongs hospitalization or requires re-hospitalization, that requires intervention to prevent permanent impairment or damage, that causes permanent disability, or that is life threatening.\n\nSAE did not include Venous thrombolembolism (VTE) events (DVT and PE) and Major bleeding complications as these are outcome measures'}, {'measure': "In-Patients' Compliance", 'timeFrame': 'Surgery till discharge', 'description': "Total usage time with the pneumatic device (patient's compliance) was recorded using the ActiveCare+SFT device internal timer.\n\nThe compliance was calculate as total actual operation time (for the entire arm/group) divided by the total time passes since the initiation of treatment at hospital (for the entire arm/group).\n\nThe compliance is expressed as percentages."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['SAFE', 'CECT', 'SFT', 'ActiveCare', 'ActiveCare+SFT', 'Deep Vein Thrombosis prevention', 'Total Hip Replacement', 'Total Hip Arthroplasty', 'Low Molecular Weight Heparin', 'MCS'], 'conditions': ['Deep Vein Thrombosis of Lower Limb', 'Pulmonary Embolism (PE)', 'Bleeding']}, 'referencesModule': {'references': [{'pmid': '20194309', 'type': 'RESULT', 'citation': 'Colwell CW Jr, Froimson MI, Mont MA, Ritter MA, Trousdale RT, Buehler KC, Spitzer A, Donaldson TK, Padgett DE. Thrombosis prevention after total hip arthroplasty: a prospective, randomized trial comparing a mobile compression device with low-molecular-weight heparin. J Bone Joint Surg Am. 2010 Mar;92(3):527-35. doi: 10.2106/JBJS.I.00047.'}], 'seeAlsoLinks': [{'url': 'http://www.mcsmed.com/uploadimages/SAFE.pdf', 'label': 'Summary and brochure of the S.A.F.E study'}]}, 'descriptionModule': {'briefSummary': 'Evaluation of the safety and effectiveness of ActiveCare+ CECT device +/- baby dose aspirin (81 mg QD) for lowering the potential risk for bleeding and of DVT during and after THA surgery in comparison with LMWH.', 'detailedDescription': 'Patients undergoing total hip arthroplasty surgery are at particular risk for Thromboembolic disease. To date two prophylactic modalities are being used: mechanical (intermittent pneumatic compression \\[IPC\\]) and pharmacological (anticoagulant). Both are effective; however each carries its own advantages and disadvantages.\n\nThe purpose of this study is to compare in total hip arthroplasty (THA) patients the safety and effectiveness of the mobile ActiveCare CECT based prophylaxis protocol and compare it with LMWH standard of care protocol for this patient population.\n\nThe protocol is based upon the CECT system as the primary DVT prophylaxis method (with or without the addition of low dose baby aspirin \\[81 mg\\]).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdult patient (Age \\>18). Patient intended to undergo elective primary unilateral THA surgery. Patient is able and willing to follow instructions of care after surgery. Patient is able and willing to sign the institution human subjects committee approved Informed Consent Form.\n\nExclusion Criteria:\n\nPatient who has a known coagulation disorder. Patient currently treated with anticoagulant medications. Patient with known thrombophilia Patient with current signs and symptoms of or history of DVT/PE. Patient who is uncooperative or unable to follow instructions. Patient currently suffering from a solid tumor malignancy. Patient with active peptic disease. Patient with known allergy to baby aspirin (81 mg) or enoxaparin. Patient with contraindication to use of the device including patients with leg gangrene, recent skin graft or medical situations where increase venous and lymphatic return is undesirable.Patient has major surgery procedure within 3 months prior to the study surgery, or patients with a major surgery procedure planning during the study period.Pregnant women.Patient who is participating in another clinical drug trial.'}, 'identificationModule': {'nctId': 'NCT00358735', 'acronym': 'SAFE', 'briefTitle': 'Deep Vein Thrombosis (DVT) Prevention in Total Hip Arthroplasty: Continuous Enhanced Circulation Therapy (CECT) Versus Low Molecular Weight Heparin (LMWH)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medical Compression Systems'}, 'officialTitle': 'Deep Vein Thrombosis (DVT) Prevention in Total Hip Arthroplasty (THA): Continuous Enhanced Circulation Therapy (CECT) Versus Low Molecular Weight Heparin (LMWH)', 'orgStudyIdInfo': {'id': 'MedicalCS06CC001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ActiveCare CECT', 'description': 'The ActiveCare CECT device is a mobile compression device used to prevent venous thromboembolic events, used after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery.', 'interventionNames': ['Device: ActiveCare CECT device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LMWH (Enoxaparin)', 'description': 'Enoxaparin (LMWH) will be used, following a protocol that is considered a standard of care for this patient population. 40mg QD for the remainder of the 10 days.', 'interventionNames': ['Drug: Enoxaparin']}], 'interventions': [{'name': 'ActiveCare CECT device', 'type': 'DEVICE', 'otherNames': ['ActiveCare+', 'ActiveCare DVT', 'ActiveCare+SFT'], 'description': 'Patients will be treated with the ActiveCare+ CECT device starting after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery. Baby aspirin (81 mg) QD can be added (depending on surgeon preference) 12-24 hours after surgery. Post discharge prophylaxis is the same for the remainder of the 10-12 days. Patients will wear the device to the duplex ultrasound when it will be discontinued by nurse.', 'armGroupLabels': ['ActiveCare CECT']}, {'name': 'Enoxaparin', 'type': 'DRUG', 'otherNames': ['Lovenox'], 'description': 'Patients will be treated with Enoxaparin (Lovenox) for a total of 10 days beginning with 30mg BID starting 12-24 hours after surgery and continued until hospital discharge. Post discharge prophylaxis will be Enoxaparin 40mg QD for the remainder of the 10 days.', 'armGroupLabels': ['LMWH (Enoxaparin)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Clinic', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92324', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Empire Orthopedic Center', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '46158', 'city': 'Mooresville', 'state': 'Indiana', 'country': 'United States', 'facility': 'The center for hip and knee surgery', 'geoPoint': {'lat': 39.61282, 'lon': -86.37416}}, {'zip': '21215', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Center for Joint Preservation and Replacement, Sinai Hospital of Baltimore', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '55902', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Hospital for Special Surgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '97701', 'city': 'Bend', 'state': 'Oregon', 'country': 'United States', 'facility': 'The Center Orthopedic & Neurosurgical Care &Research', 'geoPoint': {'lat': 44.05817, 'lon': -121.31531}}], 'overallOfficials': [{'name': 'Clifford W Colwell, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Scripps Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical Compression Systems', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}