Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-03-27 @ 3:04 AM
Study NCT ID:
NCT03143569
Status:
COMPLETED
Last Update Posted:
2020-02-25
First Post:
2017-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ventricular Assist Device Anti-Factor Xa (VAD ANTIX) Monitoring Study: a Prospective Randomized Feasibility Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006471', 'term': 'Gastrointestinal Hemorrhage'}, {'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'graetzt@wustl.edu', 'phone': '3147474155', 'title': 'Thomas J Graetz', 'organization': 'WASHINGTON UNIVERSITY'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Collected during 14 day study duration.', 'eventGroups': [{'id': 'EG000', 'title': 'aPTT Nomogram', 'description': 'aPTT guided heparin management\n\naPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device.\n\nAnti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Anti-factor Xa Nomogram', 'description': 'Anti-factor Xa guided heparin management\n\naPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device.\n\nAnti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'seriousEvents': [{'term': 'Thrombosis', 'notes': 'Thrombotic events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Nomogram Feasibility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'units': 'Surveys', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'aPTT Nomogram', 'description': 'aPTT guided heparin management\n\naPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device.'}, {'id': 'OG001', 'title': 'Anti-factor Xa Nomogram', 'description': 'Anti-factor Xa guided heparin management\n\nAnti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device'}], 'classes': [{'title': 'Surveys Completed', 'categories': [{'measurements': [{'value': '136', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}]}, {'title': 'Affirmative Responses', 'categories': [{'measurements': [{'value': '136', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.45', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '14 days of heparin therapy', 'description': 'Questionnaires evaluating pragmatic application of nomograms. Question 1: The current heparin nomogram using (aPTT or anti-Xa depending on group) monitoring is easy to follow.', 'unitOfMeasure': 'Surveys', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Surveys', 'denomUnitsSelected': 'Surveys'}, {'type': 'PRIMARY', 'title': 'Nomogram Feasibility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'units': 'Surveys', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'aPTT Nomogram', 'description': 'aPTT guided heparin management\n\naPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device.'}, {'id': 'OG001', 'title': 'Anti-factor Xa Nomogram', 'description': 'Anti-factor Xa guided heparin management\n\nAnti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device'}], 'classes': [{'title': 'Surveys Completed', 'categories': [{'measurements': [{'value': '136', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}]}, {'title': 'Affirmative Responses', 'categories': [{'measurements': [{'value': '136', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.0', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '14 days of heparin therapy', 'description': 'Questionnaires evaluating pragmatic application of nomograms. Question 2: Overall, I am satisfied with the utilization and implementation of the heparin monitoring nomogram.', 'unitOfMeasure': 'Surveys', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Surveys', 'denomUnitsSelected': 'Surveys', 'populationDescription': 'Collected Survey responses from bedside nurses. All surveys were collected as intended.'}, {'type': 'PRIMARY', 'title': 'Nomogram Feasibility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'units': 'Surveys', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'aPTT Nomogram', 'description': 'aPTT guided heparin management\n\naPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device.'}, {'id': 'OG001', 'title': 'Anti-factor Xa Nomogram', 'description': 'Anti-factor Xa guided heparin management\n\nAnti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device'}], 'classes': [{'title': 'Surveys Completed', 'categories': [{'measurements': [{'value': '136', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}]}, {'title': 'Affirmative Responses', 'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.0', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '14 days of heparin therapy', 'description': 'Questionnaires evaluating pragmatic application of nomograms. Question 3: Overall, I feel that this dosing nomogram is feasible.', 'unitOfMeasure': 'Surveys', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Surveys', 'denomUnitsSelected': 'Surveys', 'populationDescription': 'Collected Survey responses from bedside nurses. All surveys were collected as intended.'}, {'type': 'PRIMARY', 'title': 'Nomogram Feasibility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'units': 'Surveys', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'aPTT Nomogram', 'description': 'aPTT guided heparin management\n\naPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device.'}, {'id': 'OG001', 'title': 'Anti-factor Xa Nomogram', 'description': 'Anti-factor Xa guided heparin management\n\nAnti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device'}], 'classes': [{'title': 'Surveys Completed', 'categories': [{'measurements': [{'value': '136', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}]}, {'title': 'Affirmative Responses', 'categories': [{'measurements': [{'value': '136', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.0', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '14 days of heparin therapy', 'description': 'Questionnaires evaluating pragmatic application of nomograms. Question 4: When my patient is on the heparin nomogram, I follow the dosing and monitoring instructions exactly.', 'unitOfMeasure': 'Surveys', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Surveys', 'denomUnitsSelected': 'Surveys'}, {'type': 'PRIMARY', 'title': 'Nomogram Feasibility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'units': 'Surveys', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'aPTT Nomogram', 'description': 'aPTT guided heparin management\n\naPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device.'}, {'id': 'OG001', 'title': 'Anti-factor Xa Nomogram', 'description': 'Anti-factor Xa guided heparin management\n\nAnti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device'}], 'classes': [{'title': 'Surveys Completed', 'categories': [{'measurements': [{'value': '136', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}]}, {'title': 'Affirmative Responses', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.018', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '14 days of heparin therapy', 'description': 'Questionnaires evaluating pragmatic application of nomograms. Question 5: I often had to seek clarification from a coworker, pharmacist, NP, or MD regarding the nomogram instructions.', 'unitOfMeasure': 'Surveys', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Surveys', 'denomUnitsSelected': 'Surveys'}, {'type': 'PRIMARY', 'title': 'Success of Nomogram', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'aPTT Nomogram', 'description': 'aPTT guided heparin management\n\naPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device.\n\nAnti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device'}, {'id': 'OG001', 'title': 'Anti-factor Xa Nomogram', 'description': 'Anti-factor Xa guided heparin management\n\naPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device.\n\nAnti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device'}], 'classes': [{'categories': [{'measurements': [{'value': '39.8', 'groupId': 'OG000', 'lowerLimit': '33.3', 'upperLimit': '53.3'}, {'value': '55.8', 'groupId': 'OG001', 'lowerLimit': '50.0', 'upperLimit': '63.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '14 days of heparin therapy', 'description': 'Amount of time sustained in therapeutic anticoagulation range', 'unitOfMeasure': '% of time patients test was therapeutic', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Each group received heparin anticoagulation and had heparin administration guided by a nomogram based on one of two different laboratory assays, aPTT or anti-Xa.'}, {'type': 'SECONDARY', 'title': 'Nomogram Concordance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'units': 'tests', 'counts': [{'value': '416', 'groupId': 'OG000'}, {'value': '416', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'aPTT Nomogram', 'description': 'aPTT guided heparin management\n\naPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device.\n\nAnti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device'}, {'id': 'OG001', 'title': 'Anti-factor Xa Nomogram', 'description': 'Anti-factor Xa guided heparin management\n\naPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device.\n\nAnti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device'}], 'classes': [{'categories': [{'title': 'subtherapeutic', 'measurements': [{'value': '242', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}, {'title': 'therapeutic', 'measurements': [{'value': '138', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}, {'title': 'supratherapeutic', 'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '14 days of heparin therapy', 'description': 'Compare heparin dosing success between aPTT and anti-factor Xa nomograms. If aPTT was within therapeutic range of nomogram AND anti-factor Xa was within range in therapeutic nomogram, then paired values were deemed "concordent". Similiarly if both aPTT AND anti-factor Xa were above therapeutic range OR both below therapeutic range, then paired valued were deemed "concordent". Otherwise values deemd "discordant"', 'unitOfMeasure': 'tests', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'tests', 'denomUnitsSelected': 'tests', 'populationDescription': 'paired aPTT samples compared with antiXa samples'}, {'type': 'SECONDARY', 'title': 'Dosing Changes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'aPTT Nomogram', 'description': 'aPTT guided heparin management\n\naPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device.\n\nAnti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device'}, {'id': 'OG001', 'title': 'Anti-factor Xa Nomogram', 'description': 'Anti-factor Xa guided heparin management\n\naPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device.\n\nAnti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '4.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '14 days of heparin therapy', 'description': 'Number of dosing changes during heparin therapy until first therapeutic', 'unitOfMeasure': 'dosing changes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Therapeutic Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'aPTT Nomogram', 'description': 'aPTT guided heparin management\n\naPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device.\n\nAnti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device'}, {'id': 'OG001', 'title': 'Anti-factor Xa Nomogram', 'description': 'Anti-factor Xa guided heparin management\n\naPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device.\n\nAnti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device'}], 'classes': [{'categories': [{'measurements': [{'value': '48.0', 'groupId': 'OG000', 'lowerLimit': '12.0', 'upperLimit': '60.0'}, {'value': '33.0', 'groupId': 'OG001', 'lowerLimit': '6.0', 'upperLimit': '48.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '14 days of heparin therapy', 'description': 'Amount of time needed to achieve therapeutic dose from heparin initiation', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'aPTT Nomogram', 'description': 'aPTT guided heparin management\n\naPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device.\n\nAnti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device'}, {'id': 'FG001', 'title': 'Anti-factor Xa Nomogram', 'description': 'Anti-factor Xa guided heparin management\n\naPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device.\n\nAnti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'aPTT Nomogram', 'description': 'aPTT guided heparin management\n\naPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device.\n\nAnti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device'}, {'id': 'BG001', 'title': 'Anti-factor Xa Nomogram', 'description': 'Anti-factor Xa guided heparin management\n\naPTT guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device.\n\nAnti-factor Xa guided heparin management: post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.3', 'spread': '12.3', 'groupId': 'BG000'}, {'value': '50.5', 'spread': '13.4', 'groupId': 'BG001'}, {'value': '51.9', 'spread': '12.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'INTERMACS Profile score less than 4', 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'INTERMACS(R) (Interagency Registry of Mechanically Assisted Circulatory Support) patient profile at the time of implant is a general description of patients receiving LVADs. INTERMACS(R) profile 1 is in Critical cardiogenic shock. INTERMACS(R) profile 2 is in Progressive decline. INTERMACS(R) profile 3 is Stable but inotrope dependent. INTERMACS(R) profile 4 is Resting symptoms. INTERMACS(R) profile 5 is Exertion intolerant. INTERMACS(R) profile 6 is Exertion limited. INTERMACS(R) profile 7 is Advanced NYHA Class 3. The lower the INTERMACS(R) profile, the more severe their heart failure.', 'unitOfMeasure': 'Participants'}], 'populationDescription': '10 patients, that met all inclusion and exclusion criteria, were enrolled in each arm'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-08-31', 'size': 793409, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-06-27T12:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2018-07-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-17', 'studyFirstSubmitDate': '2017-04-20', 'resultsFirstSubmitDate': '2019-09-11', 'studyFirstSubmitQcDate': '2017-05-03', 'lastUpdatePostDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-17', 'studyFirstPostDateStruct': {'date': '2017-05-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nomogram Feasibility', 'timeFrame': '14 days of heparin therapy', 'description': 'Questionnaires evaluating pragmatic application of nomograms. Question 1: The current heparin nomogram using (aPTT or anti-Xa depending on group) monitoring is easy to follow.'}, {'measure': 'Nomogram Feasibility', 'timeFrame': '14 days of heparin therapy', 'description': 'Questionnaires evaluating pragmatic application of nomograms. Question 2: Overall, I am satisfied with the utilization and implementation of the heparin monitoring nomogram.'}, {'measure': 'Nomogram Feasibility', 'timeFrame': '14 days of heparin therapy', 'description': 'Questionnaires evaluating pragmatic application of nomograms. Question 3: Overall, I feel that this dosing nomogram is feasible.'}, {'measure': 'Nomogram Feasibility', 'timeFrame': '14 days of heparin therapy', 'description': 'Questionnaires evaluating pragmatic application of nomograms. Question 4: When my patient is on the heparin nomogram, I follow the dosing and monitoring instructions exactly.'}, {'measure': 'Nomogram Feasibility', 'timeFrame': '14 days of heparin therapy', 'description': 'Questionnaires evaluating pragmatic application of nomograms. Question 5: I often had to seek clarification from a coworker, pharmacist, NP, or MD regarding the nomogram instructions.'}, {'measure': 'Success of Nomogram', 'timeFrame': '14 days of heparin therapy', 'description': 'Amount of time sustained in therapeutic anticoagulation range'}], 'secondaryOutcomes': [{'measure': 'Nomogram Concordance', 'timeFrame': '14 days of heparin therapy', 'description': 'Compare heparin dosing success between aPTT and anti-factor Xa nomograms. If aPTT was within therapeutic range of nomogram AND anti-factor Xa was within range in therapeutic nomogram, then paired values were deemed "concordent". Similiarly if both aPTT AND anti-factor Xa were above therapeutic range OR both below therapeutic range, then paired valued were deemed "concordent". Otherwise values deemd "discordant"'}, {'measure': 'Dosing Changes', 'timeFrame': '14 days of heparin therapy', 'description': 'Number of dosing changes during heparin therapy until first therapeutic'}, {'measure': 'Time to Therapeutic Dose', 'timeFrame': '14 days of heparin therapy', 'description': 'Amount of time needed to achieve therapeutic dose from heparin initiation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Left Sided Heart Failure', 'Left Ventricular Assist Device', 'Anticoagulant Therapy', 'Gastro Intestinal Bleeding', 'Thrombosis, LVAD', 'Anti-factor Xa', 'aPTT', 'Heparin']}, 'descriptionModule': {'briefSummary': "This study evaluates two different methods for monitoring a patient's anti-clotting \\[heparin\\] therapy after they receive a heart pump implant \\[left ventricular assist device -LVAD\\]. One method tests for how long it takes the patient's blood to clot and uses that to determine if they are on the right dose of heparin. The other method uses a more direct measure of how much heparin is in the blood. The hypothesis is that the method that more directly measures how much heparin is in the patient's blood will provide better medical results for the patient's care after they have the heart pump implant. To that end, the investigators are conducting this feasibility trial to establish the logistics associated with the implementation of these heparin monitoring approaches.", 'detailedDescription': 'Heart failure is a medical condition that is on the rise in the US and is associated with an enormous cost of $30 billion in healthcare expenses. People with heart failure may be treated with an LVAD that is connected to their heart and helps it pump the blood from the left side of the heart into the blood vessels that delivers blood to the body. These devices can be used to treat heart failure for the long term or they can be used while a patient waits for a heart transplant. In either case, the use of these devices is increasing.\n\nOne of the primary risks associated with LVADs are those related to blood clotting. Maintenance of the LVAD depends on preventing blood clots especially right after the surgery that puts them in place. This requires putting patients with LVADs on blood thinners and then monitoring the blood thinner levels carefully so that they don\'t have problems with bleeding too easily or, on the other hand, forming blood clots if they aren\'t on the right dose of blood thinners. Excessive bleeding - called hemorrhaging - is the more common problem after surgery and half of all patients that receive an LVAD will require a blood transfusion within the first 30 days after they receive the device. A laboratory test that measures how quickly blood clots is used to determine if the patient has the right amount of blood thinners. The current standard test is called "activated partial thromboplastin time \\[aPTT\\]." There are problems with the reliability of this test because it reacts with other elements in the blood. Alternately, there is a test that more directly measures the amount of heparin blood thinner rather than coagulation time and may be more reliable than aPTT called anti-factor Xa \\[anti-Xa\\].\n\nThe investigators have developed process diagrams that show steps for making decisions \\[called nomograms\\] that tell a nurse or doctor how to manage the heparin levels using test results from the aPTT test or the anti-Xa test; however, both tests will be performed at each decision time point, but the care team will only be told the results from the testing to which their patient is assigned.\n\nThe purpose of this feasibility study is to establish feasibility of using the two nomograms to determine which provides the optimal clinical information for improving patients\' outcomes that have had LVADs placed.\n\nPotential subjects will be recruited prior to their surgery and may decline to participate anytime before or after the surgery takes place. Subjects will be randomized to the aPTT nomogram or the anti-Xa nomogram. If they withdraw consent, they will receive the aPTT standard of care monitoring. The study procedures are performed by the clinical care team. Clinicians will be trained to use the nomograms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18 years of age and older\n2. Implantation with HeartMate II® or HeartWare®, LVAD at Barnes Jewish Hospital\n\nExclusion Criteria:\n\n1. Unable to receive heparin-based therapy\n2. Hypercoagulable disorders \\[factor V Leiden, Antithrombin deficiency, Protein C deficiency, Antiphospholipid antibodies or other thrombophilia\\]\n3. Incarceration\n4. Pregnancy or breastfeeding'}, 'identificationModule': {'nctId': 'NCT03143569', 'acronym': 'VAD-ANTIX', 'briefTitle': 'Ventricular Assist Device Anti-Factor Xa (VAD ANTIX) Monitoring Study: a Prospective Randomized Feasibility Trial', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Ventricular Assist Device Anti-Factor Xa (VAD ANTIX) Monitoring Study: a Prospective Randomized Feasibility Trial', 'orgStudyIdInfo': {'id': '201701126'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'aPTT nomogram', 'description': 'aPTT guided heparin management', 'interventionNames': ['Device: aPTT guided heparin management', 'Device: Anti-factor Xa guided heparin management']}, {'type': 'EXPERIMENTAL', 'label': 'Anti-factor Xa nomogram', 'description': 'Anti-factor Xa guided heparin management', 'interventionNames': ['Device: aPTT guided heparin management', 'Device: Anti-factor Xa guided heparin management']}], 'interventions': [{'name': 'aPTT guided heparin management', 'type': 'DEVICE', 'description': 'post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device.', 'armGroupLabels': ['Anti-factor Xa nomogram', 'aPTT nomogram']}, {'name': 'Anti-factor Xa guided heparin management', 'type': 'DEVICE', 'description': 'post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device', 'armGroupLabels': ['Anti-factor Xa nomogram', 'aPTT nomogram']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University in St Louis School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Thomas J Graetz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept of Anesthesiology, Washington University STL SOM'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc Prof of Anesthesiology', 'investigatorFullName': 'Thomas Graetz', 'investigatorAffiliation': 'Washington University School of Medicine'}}}}