Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2026-03-01 @ 10:10 AM
Study NCT ID:
NCT02398305
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2014-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Shortening Compression Time After Radial Access for Cardiac Catheterisation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 173}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-24', 'studyFirstSubmitDate': '2014-12-04', 'studyFirstSubmitQcDate': '2015-03-24', 'lastUpdatePostDateStruct': {'date': '2015-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bleeding', 'timeFrame': '1 year', 'description': 'Bleeding at puncture site after deflating pressure in TR band'}], 'secondaryOutcomes': [{'measure': 'Swelling', 'timeFrame': '1 year', 'description': 'Swelling at puncture site that is not caused by bleeding'}, {'measure': 'Patient comfort', 'timeFrame': '1 year', 'description': 'Patient comfort, measured on VAS'}, {'measure': 'Time to discharge, after return on nursing unit', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cardiac catheterisation', 'Radial access', 'Compression', 'Terumo TR Band', 'radial artery', 'diagnostic'], 'conditions': ['Cardiac Catheterisation']}, 'descriptionModule': {'briefSummary': 'To obtain arterial access for a diagnostic cardiac catheterization or percutaneous coronary intervention (PCI) the cardiologist can choose between the femoral artery and the radial artery. In the University Medical Center Groningen the femoral artery is commonly used. After intervention the puncture site is closed with an arteriotomy closure device (ACD). Patients after radial access receive a pressure bandage at the puncture site, usually the Terumo (TR) wrist bandage.\n\nThe bedrest period for patients with an ACD is 1 hour after diagnostic cardiac catheterization and 2 hours after PCI. After the bedrest period patients are discharged 1 hour after diagnostic procedures or 4 hours after PCI. This to observe potential bleeding complications after the procedure. In patients with radial access, the TR bandage will be removed according to current protocol after 4 hours and additionally 1 hour observation is required. Several cardiologists have the intention to use the radial artery more frequent for cardiac catheterization or PCI. In a meta-analysis radial access is related to a 73% decrease in major bleeding complications compared to femoral access. Also there are no significant differences in MACE. Even so there are no differences in success percentage for cardiac catheterization or PCI and admission time is shorter for radial access (Am Heart J. 2009 Jan;157(1):132- 40). Admission time for diagnostic cardiac catheterization at the short-stay unit is in case of femoral access with an ACD approximately 2 hours. For patients after radial access post procedural admission time is approximately 5 hours. To guarantee patient throughput, uniformity of care and more efficient use of capacity of the short-stay unit, patients after radial access should not have a longer hospital admission time than patients after femoral access. Carrington et al. (J Interv Cardiol. 2009 Dec;22(6):571-5) have shown that it is safe to deflate the TR wrist band faster than four hours.\n\nObjective of the study:\n\nTo describe the differences in safety, patient comfort and admission period after diagnostic cardiac catheterization through radial access, between the current protocol and the protocol of fast desufflation by Carrington et al.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnostic coronary angiogram\n* Radial access\n* 6 French sheath\n\nExclusion Criteria:\n\n* Use of oral anticoagulants\n* Percutaneous coronary intervention'}, 'identificationModule': {'nctId': 'NCT02398305', 'briefTitle': 'Shortening Compression Time After Radial Access for Cardiac Catheterisation', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': 'Shortening Compression Time of the Access Site After Cardiac Catheterisation Through the Radial Artery', 'orgStudyIdInfo': {'id': 'METc2011-233'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TR Band accelerated', 'description': 'Diminishing air pressure in the TR Band using accelerated protocol', 'interventionNames': ['Device: TR Band Quick']}, {'type': 'OTHER', 'label': 'TR band standard', 'description': 'Diminishing air pressure in the TR band according to standard care', 'interventionNames': ['Device: TR Band standard']}], 'interventions': [{'name': 'TR Band standard', 'type': 'DEVICE', 'description': 'Diminishing the air pressure in the TR Band following standard protocol', 'armGroupLabels': ['TR band standard']}, {'name': 'TR Band Quick', 'type': 'DEVICE', 'description': 'Diminishing the air pressure in the TR Band following a faster protocol', 'armGroupLabels': ['TR Band accelerated']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9713GZ', 'city': 'Groningen', 'state': 'Provincie Groningen', 'country': 'Netherlands', 'facility': 'University Medical Centre Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'overallOfficials': [{'name': 'Pim van der Harst, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Medical Center Groningen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MANP', 'investigatorFullName': 'J.H.H. (Han) Deuling', 'investigatorAffiliation': 'University Medical Center Groningen'}}}}