Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-03-15 @ 10:08 PM
Study NCT ID:
NCT03318393
Status:
COMPLETED
Last Update Posted:
2023-01-31
First Post:
2017-10-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric ECMO
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-11-09', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C074619', 'term': 'bivalirudin'}, {'id': 'D006493', 'term': 'Heparin'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lakshmi.raman@utsw.edu', 'phone': '214-456-6222', 'title': 'Lakshmi Raman', 'organization': 'UT Southwestern Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From Baseline, daily until the end of study, an average of up to 0.1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Unfractionated Heparin Group', 'description': 'Patients randomized to this arm will undergo usual care using unfractionated heparin as the primary anticoagulant.\n\nUnfractionated heparin: Continuous infusion', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 2, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Bivalirudin Group', 'description': 'Patients randomized to this arm will receive anticoagulation with bivalirudin\n\nBivalirudin: Continuous infusion', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 3, 'seriousNumAffected': 7}], 'seriousEvents': [{'term': 'Major bleeding event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Time Spent at Goal Anticoagulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unfractionated Heparin Group', 'description': 'Patients randomized to this arm will undergo usual care using unfractionated heparin as the primary anticoagulant.\n\nUnfractionated heparin: Continuous infusion'}, {'id': 'OG001', 'title': 'Bivalirudin Group', 'description': 'Patients randomized to this arm will receive anticoagulation with bivalirudin\n\nBivalirudin: Continuous infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '0.63', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '0.82'}, {'value': '0.49', 'groupId': 'OG001', 'lowerLimit': '0.31', 'upperLimit': '0.54'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'through study completion, an average of 1-2 weeks', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With One or More Major Bleeding Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unfractionated Heparin Group', 'description': 'Patients randomized to this arm will undergo usual care using unfractionated heparin as the primary anticoagulant.\n\nUnfractionated heparin: Continuous infusion'}, {'id': 'OG001', 'title': 'Bivalirudin Group', 'description': 'Patients randomized to this arm will receive anticoagulation with bivalirudin\n\nBivalirudin: Continuous infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'through study completion, an average of 1-2 weeks', 'description': 'Bleeding events will include drop in hemoglobin, surgical site bleeding, intracranial hemorrhage, fatal bleeding, extra surgical or unexpected surgical site bleeding', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Blood Products Transfused', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Unfractionated Heparin Group', 'description': 'Patients randomized to this arm will undergo usual care using unfractionated heparin as the primary anticoagulant.\n\nUnfractionated heparin: Continuous infusion'}, {'id': 'OG001', 'title': 'Bivalirudin Group', 'description': 'Patients randomized to this arm will receive anticoagulation with bivalirudin\n\nBivalirudin: Continuous infusion'}], 'classes': [{'title': 'pRBCs', 'categories': [{'measurements': [{'value': '12.2', 'groupId': 'OG000', 'lowerLimit': '5.52', 'upperLimit': '14.46'}, {'value': '6.29', 'groupId': 'OG001', 'lowerLimit': '2.49', 'upperLimit': '8.41'}]}]}, {'title': 'Platelets', 'categories': [{'measurements': [{'value': '13.58', 'groupId': 'OG000', 'lowerLimit': '2.43', 'upperLimit': '23.94'}, {'value': '4.55', 'groupId': 'OG001', 'lowerLimit': '0.55', 'upperLimit': '11.51'}]}]}, {'title': 'FFP', 'categories': [{'measurements': [{'value': '0.16', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2.84'}, {'value': '1.15', 'groupId': 'OG001', 'lowerLimit': '0.24', 'upperLimit': '2.79'}]}]}, {'title': 'Cryoprecipitate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.19'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1.14'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'through study completion, an average of 1-2 weeks', 'description': 'Will include fresh frozen plasma (FFP), packed red blood cells (pRBCs), platelets and cryoprecipitate', 'unitOfMeasure': 'mls/kg/day', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Unfractionated Heparin Group', 'description': 'Patients randomized to this arm will undergo usual care using unfractionated heparin as the primary anticoagulant.\n\nUnfractionated heparin: Continuous infusion'}, {'id': 'FG001', 'title': 'Bivalirudin Group', 'description': 'Patients randomized to this arm will receive anticoagulation with bivalirudin\n\nBivalirudin: Continuous infusion'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Unfractionated Heparin Group', 'description': 'Patients randomized to this arm will undergo usual care using unfractionated heparin as the primary anticoagulant.\n\nUnfractionated heparin: Continuous infusion'}, {'id': 'BG001', 'title': 'Bivalirudin Group', 'description': 'Patients randomized to this arm will receive anticoagulation with bivalirudin\n\nBivalirudin: Continuous infusion'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-29', 'size': 331639, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-10-11T18:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2021-10-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-28', 'studyFirstSubmitDate': '2017-10-04', 'resultsFirstSubmitDate': '2022-10-11', 'studyFirstSubmitQcDate': '2017-10-20', 'lastUpdatePostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-28', 'studyFirstPostDateStruct': {'date': '2017-10-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Blood Products Transfused', 'timeFrame': 'through study completion, an average of 1-2 weeks', 'description': 'Will include fresh frozen plasma (FFP), packed red blood cells (pRBCs), platelets and cryoprecipitate'}], 'primaryOutcomes': [{'measure': 'Percentage of Time Spent at Goal Anticoagulation', 'timeFrame': 'through study completion, an average of 1-2 weeks'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With One or More Major Bleeding Events', 'timeFrame': 'through study completion, an average of 1-2 weeks', 'description': 'Bleeding events will include drop in hemoglobin, surgical site bleeding, intracranial hemorrhage, fatal bleeding, extra surgical or unexpected surgical site bleeding'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Extracorporeal Membrane Oxygenation Complication', 'Pediatric ALL', 'Anticoagulants']}, 'referencesModule': {'references': [{'pmid': '39585174', 'type': 'DERIVED', 'citation': 'McMichael A, Weller J, Li X, Hatton L, Zia A, Raman L. Prospective Randomized Pilot Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric Extracorporeal Membrane Oxygenation. Pediatr Crit Care Med. 2025 Jan 1;26(1):e86-e94. doi: 10.1097/PCC.0000000000003642. Epub 2024 Nov 25.'}]}, 'descriptionModule': {'briefSummary': 'The investigators will prospectively enroll 30 neonatal and pediatric ECMO patients at a single pediatric Level 1 trauma center. The patients will be randomized into two arms; one arm will receive unfractionated heparin and the other arm will receive bivalirudin. There will be 15 patients in each arm for a total of 30 patients.\n\nPrimary aim will be to compare the efficacy of bivalirudin to unfractionated heparin.', 'detailedDescription': 'The investigators will prospectively enroll 30 neonatal and pediatric ECMO patients at a single pediatric Level 1 trauma center. The patients will be randomized into two arms; one arm will receive unfractionated heparin and the other arm will receive bivalirudin. There will be 15 patients in each arm for a total of 30 patients.\n\nThe investigators hypothesize that neonatal and pediatric ECMO patients receiving bivalirudin will spend more time at goal anticoagulation and will experience less hemorrhagic and thrombotic complications when compared to patients receiving unfractionated heparin. Primary aim will be to compare the efficacy of bivalirudin to unfractionated heparin. The investigators secondary aim will be to define the incidence of hemorrhagic and thrombotic complications in patients receiving bivalirudin during ECMO.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 1 day to less than 18 years\n* Cared for in the pediatric intensive care unit or pediatric cardiac intensive care unit\n* receiving venovenous or venoarterial ECMO\n\nExclusion Criteria:\n\n* Patients with known or suspected heparin induced thrombocytopenia prior to consent\n* Patients with hepatic failure defined as coagulopathy with elevated transaminases more than three times normal values\n* Patients with plan to decannulate from ECMO within 48 hours\n* Known or suspected pregnant women\n* Previous enrollment in this study\n* Primary language spoken that is not English or Spanish'}, 'identificationModule': {'nctId': 'NCT03318393', 'briefTitle': 'Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric ECMO', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Prospective Randomized Pilot Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric Extracorporeal Membrane Oxygenation', 'orgStudyIdInfo': {'id': '072017-045'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Unfractionated heparin group', 'description': 'Patients randomized to this arm will undergo usual care using unfractionated heparin as the primary anticoagulant.', 'interventionNames': ['Drug: Unfractionated heparin']}, {'type': 'EXPERIMENTAL', 'label': 'Bivalirudin group', 'description': 'Patients randomized to this arm will receive anticoagulation with bivalirudin', 'interventionNames': ['Drug: Bivalirudin']}], 'interventions': [{'name': 'Bivalirudin', 'type': 'DRUG', 'description': 'Continuous infusion', 'armGroupLabels': ['Bivalirudin group']}, {'name': 'Unfractionated heparin', 'type': 'DRUG', 'description': 'Continuous infusion', 'armGroupLabels': ['Unfractionated heparin group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': "Children's Medical Center", 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Ali McMichael, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UT Southwestern'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PROFESSOR', 'investigatorFullName': 'Lakshmi Raman', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}