Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-03-06 @ 8:03 AM
Study NCT ID:
NCT03725293
Status:
COMPLETED
Last Update Posted:
2022-01-14
First Post:
2018-10-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Midlines and Thrombophlebitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-12-29', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ahmit.bahl@beaumont.edu', 'phone': '(248) 898-9111', 'title': 'Amit Bahl, MD', 'organization': 'Beaumont Hospitals'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '30 days post line insertion', 'eventGroups': [{'id': 'EG000', 'title': 'Angiodynamics BioFlo Midline Catheter', 'description': 'Placement of clinically indicated Angiodynamics BioFlo midline catheter.\n\nAngiodynamics BioFlo Midline Catheter: Placement of Angiodynamics BioFlo Midline Catheter.', 'otherNumAtRisk': 94, 'deathsNumAtRisk': 94, 'otherNumAffected': 22, 'seriousNumAtRisk': 94, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Teleflex Arrowg+Ard Blue Advanced Midline Catheter', 'description': 'Placement of clinically indicated Teleflex Arrowg+ard Blue Advanced Midline Catheter\n\nTeleflex Arrowg+ard Blue Advanced Midline Catheter: Placement of Teleflex Arrowg+ard Blue Advanced Midline Catheter.', 'otherNumAtRisk': 97, 'deathsNumAtRisk': 97, 'otherNumAffected': 20, 'seriousNumAtRisk': 97, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Catheter Failure', 'notes': 'Catheter failure prior to completion of therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 20}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Upper Extremity CR-UEVT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Angiodynamics BioFlo Midline Catheter', 'description': 'Placement of clinically indicated Angiodynamics BioFlo midline catheter.\n\nAngiodynamics BioFlo Midline Catheter: Placement of Angiodynamics BioFlo Midline Catheter.'}, {'id': 'OG001', 'title': 'Teleflex Arrowg+Ard Blue Advanced Midline Catheter', 'description': 'Placement of clinically indicated Teleflex Arrowg+ard Blue Advanced Midline Catheter\n\nTeleflex Arrowg+ard Blue Advanced Midline Catheter: Placement of Teleflex Arrowg+ard Blue Advanced Midline Catheter.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days post line insertion', 'description': 'Number of participants with proven sonographic diagnosis of DVT and/or SVT', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Line Related Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Angiodynamics BioFlo Midline Catheter', 'description': 'Placement of clinically indicated Angiodynamics BioFlo midline catheter.\n\nAngiodynamics BioFlo Midline Catheter: Placement of Angiodynamics BioFlo Midline Catheter.'}, {'id': 'OG001', 'title': 'Teleflex Arrowg+Ard Blue Advanced Midline Catheter', 'description': 'Placement of clinically indicated Teleflex Arrowg+ard Blue Advanced Midline Catheter\n\nTeleflex Arrowg+ard Blue Advanced Midline Catheter: Placement of Teleflex Arrowg+ard Blue Advanced Midline Catheter.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days post line insertion', 'description': 'Number of participants with catheter related laboratory confirmed bloodstream infection per Centers for Disease Control (CDC) guidelines', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Angiodynamics BioFlo Midline Catheter', 'description': 'Placement of clinically indicated Angiodynamics BioFlo midline catheter.\n\nAngiodynamics BioFlo Midline Catheter: Placement of Angiodynamics BioFlo Midline Catheter.'}, {'id': 'FG001', 'title': 'Teleflex Arrowg+Ard Blue Advanced Midline Catheter', 'description': 'Placement of clinically indicated Teleflex Arrowg+ard Blue Advanced Midline Catheter\n\nTeleflex Arrowg+ard Blue Advanced Midline Catheter: Placement of Teleflex Arrowg+ard Blue Advanced Midline Catheter.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}, {'groupId': 'FG001', 'numSubjects': '106'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '97'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'alternative vascular access needs', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'venous anatomy screen failures', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '191', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Angiodynamics BioFlo Midline Catheter', 'description': 'Placement of clinically indicated Angiodynamics BioFlo midline catheter.\n\nAngiodynamics BioFlo Midline Catheter: Placement of Angiodynamics BioFlo Midline Catheter.'}, {'id': 'BG001', 'title': 'Teleflex Arrowg+Ard Blue Advanced Midline Catheter', 'description': 'Placement of clinically indicated Teleflex Arrowg+ard Blue Advanced Midline Catheter\n\nTeleflex Arrowg+ard Blue Advanced Midline Catheter: Placement of Teleflex Arrowg+ard Blue Advanced Midline Catheter.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '191', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '60.29', 'spread': '16.3', 'groupId': 'BG000'}, {'value': '59.5', 'spread': '17.1', 'groupId': 'BG001'}, {'value': '60.2', 'spread': '16.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '191', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '77', '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': '94', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '191', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '191', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-04-30', 'size': 3444912, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-12-02T08:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective single-site, parallel, two-arm, randomized investigation'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 212}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2020-11-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-06', 'studyFirstSubmitDate': '2018-10-25', 'resultsFirstSubmitDate': '2021-12-02', 'studyFirstSubmitQcDate': '2018-10-29', 'lastUpdatePostDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-01-06', 'studyFirstPostDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Upper Extremity CR-UEVT', 'timeFrame': '30 days post line insertion', 'description': 'Number of participants with proven sonographic diagnosis of DVT and/or SVT'}], 'secondaryOutcomes': [{'measure': 'Line Related Infection', 'timeFrame': '30 days post line insertion', 'description': 'Number of participants with catheter related laboratory confirmed bloodstream infection per Centers for Disease Control (CDC) guidelines'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['thrombosis', 'superficial venous thrombosis', 'deep venous thrombosis', 'line related infection', 'catheter survival'], 'conditions': ['Catheter Infection', 'Catheter Thrombosis', 'Catheter Complications']}, 'referencesModule': {'references': [{'pmid': '37611283', 'type': 'DERIVED', 'citation': 'Bahl A, Johnson S, Mielke N, Chen NW. Risk Factors for Coated Midline Catheter-Related Thrombosis: A Secondary Analysis of Existing Trial Data. J Infus Nurs. 2023 Sep-Oct 01;46(5):259-265. doi: 10.1097/NAN.0000000000000518.'}, {'pmid': '34613402', 'type': 'DERIVED', 'citation': 'Bahl A, Diloreto E, Jankowski D, Hijazi M, Chen NW. Comparison of 2 Midline Catheter Devices With Differing Antithrombogenic Mechanisms for Catheter-Related Thrombosis: A Randomized Clinical Trial. JAMA Netw Open. 2021 Oct 1;4(10):e2127836. doi: 10.1001/jamanetworkopen.2021.27836.'}]}, 'descriptionModule': {'briefSummary': 'Peripherally inserted central catheters (PICCs) are central catheters that are placed via peripheral vein under ultrasound guidance and may be used for patients with difficult venous access for long-term central or peripheral infusion therapies as well as central venous pressure monitoring in a critical care setting. Although PICCs provide a great option for some patients, these catheters have known complications including catheter-related bloodstream infection, catheter-related venous thrombosis or clotting, malfunction, and high cost. Midline catheters represent a potentially attractive alternative to PICCs for peripheral infusions. As midlines have increased in popularity and new midlines have been introduced into the market, it is necessary to better understand complication profiles of various midline catheters, as it is likely that all catheters are not created equal. Specifically, the incidence of symptomatic catheter-related thrombosis is of interest. Some midline catheters are coated to provide protection against catheter-related venous thrombosis and/or catheter-related bloodstream infection. The theoretical benefit(s) of these catheters need further validation in human subjects.', 'detailedDescription': 'Study Design\n\nThe investigators propose a prospective single-site, parallel, two-arm, randomized investigation to assess catheter-related symptomatic upper extremity venous thrombosis (CR-UEVT), catheter-related bloodstream infection, and functionality of two single lumen midline catheters: AngioDynamics BioFlo 4 F and Teleflex Arrowg+ard Blue Advance 4.5 F.\n\nResearch staff of Beaumont Health Institute will allocate two midline catheters to eligible participants according to a pre-generated randomized list at a 1:1 ratio in block randomization to AngioDynamics BioFlo or Tele-flex Arrowg+ard Blue Advanced midline catheters. Participant enrollment will take place from November 2018 until recruitment of 250 participants, 125 in each group, is complete. Demographic and health-related information will be obtained from electronic medical records during enrolled period at William Beaumont Hospital.\n\nPractitioner Participation/Training\n\nAdvanced Practice Providers within the bedside PICC/Midline service at the Royal Oak campus are eligible to place catheters for this study. All investigators are credentialed in placing PICCs and midlines by institutional policy and have greater than one year of experience in these procedures.\n\nInitial Assessment\n\nPost-cannulation and post securement, functionality is confirmed with blood sampling (10 cc) and flush without resistance.\n\nThe research team also will document practitioner details, the vascular access device (VAD) used, the time of VAD placement, number of attempts, need for a rescue inserter, the vein that was cannulated, depth and diameter of the vein, and the indication for VAD placement. An attempt is defined as each time the needle punctures the skin. Data will be collected from the electronic medical record and includes: age, gender, body mass index (BMI), vital signs, relevant past medical history. Indication for catheter placement will also be recorded.\n\nFollow-up Assessment\n\nInvestigators will perform a follow-up assessment on all catheters within 24 hours of insertion and then daily for the life of the VAD. At each follow-up interval, the researcher will document the time of evaluation and assessment of functionality as well as review the patient chart for signs and symptoms of catheter-related bloodstream infection. If the catheter was identified to have failed during follow-up assessment the date and time of failure and the reason for failure will be documented. For all failed catheters, re-insertion attempt data will be tracked through the medical record.\n\nSuperficial venous thrombosis (SVT) and deep venous thrombosis (DVT) rates will be calculated based on upper extremity proven diagnosis of SVT and/or DVT in symptomatic cases. Radiology interpretations will be reviewed for findings consistent with CR-UEVT.\n\nInfection rate will be tracked using confirmed catheter-related blood stream infection data from the surveillance team within the epidemiology department. The team utilizes the CDC definition of laboratory-confirmed blood-stream infection (LCBSI).\n\nThe medication administration record will be queried for all medications given through each catheter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All inpatients 18 years of age and older\n* Inpatients that require midline catheter placement by the bedside vascular access team\n\nExclusion Criteria:\n\n* Do not meet inclusion criteria\n* Multiple lumens required\n* Alternative diameter of catheter used\n* If already enrolled once prior\n* Withdraw voluntarily from the study\n* Actively (within 24 hours) taking a therapeutic dose of an anticoagulant (heparin, low molecular weight heparin, enoxaparin, rivaroxaban, apixaban, dabigatran, edoxaban, warfarin, arixtra, factor Xa inhibitors)\n* Receiving a midline catheter for anticoagulant therapy'}, 'identificationModule': {'nctId': 'NCT03725293', 'briefTitle': 'Midlines and Thrombophlebitis', 'organization': {'class': 'OTHER', 'fullName': 'Corewell Health East'}, 'officialTitle': 'Randomized Comparative Evaluation of Midline Catheters for Thrombophlebitis', 'orgStudyIdInfo': {'id': '2018-379'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Angiodynamics BioFlo Midline Catheter', 'description': 'Placement of clinically indicated Angiodynamics BioFlo midline catheter.', 'interventionNames': ['Device: Angiodynamics BioFlo Midline Catheter']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Teleflex Arrowg+ard Blue Advanced Midline Catheter', 'description': 'Placement of clinically indicated Teleflex Arrowg+ard Blue Advanced Midline Catheter', 'interventionNames': ['Device: Teleflex Arrowg+ard Blue Advanced Midline Catheter']}], 'interventions': [{'name': 'Angiodynamics BioFlo Midline Catheter', 'type': 'DEVICE', 'description': 'Placement of Angiodynamics BioFlo Midline Catheter.', 'armGroupLabels': ['Angiodynamics BioFlo Midline Catheter']}, {'name': 'Teleflex Arrowg+ard Blue Advanced Midline Catheter', 'type': 'DEVICE', 'description': 'Placement of Teleflex Arrowg+ard Blue Advanced Midline Catheter.', 'armGroupLabels': ['Teleflex Arrowg+ard Blue Advanced Midline Catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'Beaumont Hospital - Royal Oak', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}], 'overallOfficials': [{'name': 'Amit Bahl, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Corewell Health East'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corewell Health East', 'class': 'OTHER'}, 'collaborators': [{'name': 'Teleflex', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Emergency Ultrasound', 'investigatorFullName': 'Amit Bahl', 'investigatorAffiliation': 'Corewell Health East'}}}}