Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2025-12-24 @ 6:42 PM
Study NCT ID:
NCT03976557
Status:
TERMINATED
Last Update Posted:
2021-01-22
First Post:
2019-06-04
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
BIP CVC in Access Center at Danderyd Hospital, Stockholm, Sweden
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055499', 'term': 'Catheter-Related Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Pilot, randomized, open label, controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'whyStopped': 'Due to Corona/Covid19 pandemic', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-04-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-19', 'studyFirstSubmitDate': '2019-06-04', 'studyFirstSubmitQcDate': '2019-06-04', 'lastUpdatePostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with catheter related complications', 'timeFrame': 'From CVC insertion until CVC withdrawal', 'description': 'Patients having any complication specified as secondary endpoints'}], 'secondaryOutcomes': [{'measure': 'Number of patients with CRBSI', 'timeFrame': 'From CVC insertion until CVC withdrawal', 'description': 'CRBSI - Catheter Related Blood Stream Infections'}, {'measure': 'Number of patients with CRI', 'timeFrame': 'From CVC insertion until CVC withdrawal', 'description': 'CRI - Catheter Related Infections'}, {'measure': 'Number of patients with local CVC infections', 'timeFrame': 'From CVC insertion until CVC withdrawal', 'description': 'Skin infection at the insertion site'}, {'measure': 'Number of CVC exchanges per patient due to suspected infection or thrombosis', 'timeFrame': 'From CVC insertion until CVC withdrawal', 'description': 'Reported as incidence'}, {'measure': 'Number of patients with stop or slower flow in any CVC lumen', 'timeFrame': 'From CVC insertion until CVC withdrawal', 'description': 'Stop or slower flow or need of high pressure during blood sample withdrawal and/or injection of solution'}, {'measure': 'Number of patients with local thrombosis', 'timeFrame': 'From CVC insertion until CVC withdrawal', 'description': 'Local thrombosis - thrombosis in the insertion vein'}, {'measure': 'Number of patients with device malfunctions', 'timeFrame': 'From CVC insertion until CVC withdrawal', 'description': 'Any device malfunction or technical problems during insertion, withdrawal or use'}, {'measure': 'Number of patients with antibiotics and antithrombotics drug use', 'timeFrame': 'From CVC insertion until CVC withdrawal', 'description': 'including the reason of use and dose / number of days'}, {'measure': 'Number of patients with adverse events', 'timeFrame': 'From CVC insertion until CVC withdrawal', 'description': 'including casuality assessment to the CVC use; both serious and non-serious'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vascular Access Complication', 'Catheter-Related Infections', 'Catheter Thrombosis', 'Catheter Blockage', 'Catheter Complications', 'Catheter Site Discomfort', 'Catheter Bacteraemia']}, 'descriptionModule': {'briefSummary': 'Primary objective of the study is to establish the incidence of all any catheter related complications in BIP CVC and standard CVC groups in patients requiring CVC.\n\n(CVC - Central Venous Catheter; BIP - Bactiguard Infection Protection)', 'detailedDescription': 'Catheter related complications include CRBSI, CRI, Local CVC infection, need to exchange of CVC due to suspected CRI/CRBSI or thrombosis, stop / slower flow in any CVC lumen, local thrombosis, device malfunctions / technical catheter problems, device related adverse events.\n\n(CRBSI - Catheter Related Blood Stream Infection; CRI - Catheter Related Infection)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients admitted to the Access Center at Danderyd who need an elective CVC (surgery, infection, nutrition, medication…)\n2. Fully recognize and understand patient information\n3. Signed informed consent\n\nExclusion Criteria:\n\n1. If CVC present prior to inclusion in the study and no intention to change the present CVC over guidewire\n2. Age \\< 18 years\n3. Pregnant women\n4. Known allergy to gold, silver and palladium\n5. Participation in other clinical studies which may interfere with this study as judged by the Investigator'}, 'identificationModule': {'nctId': 'NCT03976557', 'acronym': 'IMPROWE', 'briefTitle': 'BIP CVC in Access Center at Danderyd Hospital, Stockholm, Sweden', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bactiguard AB'}, 'officialTitle': 'Implementation and Evaluation of BIP CVC in Access Center at Danderyd Hospital, Stockholm, Sweden. Study Protocol', 'orgStudyIdInfo': {'id': 'PL-13732'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BIP CVC', 'description': 'Polyurethane CVC with noble metal coating', 'interventionNames': ['Device: BIP CVC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard CVC', 'description': 'Standard CVC made of polyurethane', 'interventionNames': ['Device: Standard CVC']}], 'interventions': [{'name': 'BIP CVC', 'type': 'DEVICE', 'otherNames': ['Noble metal coated CVC'], 'description': 'Central venous access with noble metal coated CVC', 'armGroupLabels': ['BIP CVC']}, {'name': 'Standard CVC', 'type': 'DEVICE', 'otherNames': ['Uncoated CVC'], 'description': 'Central venous access with standard uncoated CVC', 'armGroupLabels': ['Standard CVC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18288', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Danderyd Sjukhus', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Jan Jakobsson, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Danderyd Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bactiguard AB', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Danderyd Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}