Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2025-12-25 @ 11:30 PM
Study NCT ID:
NCT01578993
Status:
COMPLETED
Last Update Posted:
2016-03-16
First Post:
2012-04-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Observational Study of Complications Related to Use of Peripherally Inserted Central Catheters
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ulla.wallin@semprusbio.com', 'phone': '1-617-577-2205', 'title': 'Ulla Wallin, Director of Clinical Research', 'organization': 'Semprus BioSciences'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Further comparative studies standarizing the management of PICC line flushing solutions and type if PICC line required to provide comparative and evidence based clinical practice recommendations.'}}, 'adverseEventsModule': {'timeFrame': 'This observationaol study included recording of line occlusions and incidence of venous thrombosis from the time of PICC insertion until removal of the PICC line or for a maximum of 90 days.', 'eventGroups': [{'id': 'EG000', 'title': 'Single Arm Study', 'description': 'Patients requiring a standard 5 Fr Dual Lumen Peripherally Inserted Central Catheter (PICC) for an anticipated minimum 14 Days of antibiotic, chemotherpay or nutritional support were eligible for enrollment into this observational study.', 'otherNumAtRisk': 101, 'otherNumAffected': 6, 'seriousNumAtRisk': 101, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Venous thrombosis', 'notes': 'Symptomatic venous thrombus in upper extremity ( PICC arm); verified via standard ultrasonography procedure.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rate of PICC Line Occlusions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Study', 'description': 'Patients requiring a standard 5 Fr Dual Lumen Peripherally Inserted Central Catheter (PICC) for an anticipated minimum 14 Days of antibiotic, chemotherpay or nutritional support were eligible for enrollment into this observational study.'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Insertion to Removal / maximum 3 months', 'description': 'The incidence, severity and management of PICC line occlusions were recorded for each of the enrolled subjects.', 'unitOfMeasure': 'percentage of enrolled subjects', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Single Arm Study', 'description': 'Patients requiring a standard 5 Fr Dual Lumen Peripherally Inserted Central Catheter (PICC) for an anticipated minimum 14 Days of antibiotic, chemotherpay or nutritional support were eligible for enrollment into this observational study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Single Arm Study', 'description': 'Patients requiring a standard 5 Fr Dual Lumen Peripherally Inserted Central Catheter (PICC) for an anticipated minimum 14 Days of antibiotic, chemotherpay or nutritional support were eligible for enrollment into this observational study.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '83'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '65', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '88', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '101', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-18', 'studyFirstSubmitDate': '2012-04-12', 'resultsFirstSubmitDate': '2014-05-21', 'studyFirstSubmitQcDate': '2012-04-16', 'lastUpdatePostDateStruct': {'date': '2016-03-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-05-21', 'studyFirstPostDateStruct': {'date': '2012-04-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of PICC Line Occlusions', 'timeFrame': 'Insertion to Removal / maximum 3 months', 'description': 'The incidence, severity and management of PICC line occlusions were recorded for each of the enrolled subjects.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Adult Patients With Peripherally Inserted Central Catheters']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the rate and timing of interventions and complications related to the use of peripherally inserted central venous catheters in adult patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients necessitating insertion of a PICC for fluid, nutritional, chemotherapy or antibiotic treatment for a minimum of 14 days.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or Female Age \\> 18 years requiring central venous access\n* Ability to comply with study requirements\n* Written Informed Consent\n\nExclusion Criteria:\n\n* Previous enrollment in study\n* Current or recent upper extremity thrombosis, occlusion or stenosis\n* Previous axillary lymph node dissection\n* Skin inflammatory condition or rashes within 15 cm from insertion site\n* Pre-existing history of hypercoagulability unrelated to malignant disease\n* Participating in trial involving antithrombotic, anticoagulant or anti- infective drug therapies\n* Positive blood culture within 48 hours from planned PICC placement\n* Known, renal insufficiency with chronic creatinine levels \\> 1.7 mg/dl'}, 'identificationModule': {'nctId': 'NCT01578993', 'acronym': 'PRISM-1', 'briefTitle': 'Observational Study of Complications Related to Use of Peripherally Inserted Central Catheters', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teleflex'}, 'officialTitle': 'A Phase IV, Prospective Clinical Evaluation of Complications Related to the Use of Peripherally Inserted Central Catheters (PICC) - An Observational Baseline Multicenter Study.', 'orgStudyIdInfo': {'id': 'S-PICC 2012-01'}}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Ronald Reagan UCLA Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teleflex', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}