Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-02-24 @ 3:22 AM
Study NCT ID:
NCT02307318
Status:
COMPLETED
Last Update Posted:
2017-01-11
First Post:
2014-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Heart and Hands Study II: A Retrospective Data Collection & Analysis Project
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'afehrer@healtheast.org', 'phone': '651-232-5363', 'title': 'Amy Fehrer', 'organization': 'HealthEast Care System'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'SoftSeal Hemostatic Pad', 'description': 'This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram.', 'otherNumAtRisk': 51, 'otherNumAffected': 0, 'seriousNumAtRisk': 51, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Arterial Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SoftSeal Hemostatic Pad', 'description': 'This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day1', 'description': 'Number of patients who experience arterial bleeding after use of the Softseal hemostatic device and manual compression at the transradial access site as measured by observation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Incidence of Thrombosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SoftSeal Hemostatic Pad', 'description': 'This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 hours post-surgery', 'description': 'Number of patients who experience thrombosis (blood clot) at the access site as measured by ultrasound between 4 hours and 24 hours post-procedure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in Circulation, Movement and Sensation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SoftSeal Hemostatic Pad', 'description': 'This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day1', 'description': 'Number of patients who experience changes in circulation, movement and sensation in the hand and wrist of the access site as measured by standard of care nursing assessments.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Hematoma and/or Ecchymosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SoftSeal Hemostatic Pad', 'description': 'This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day1', 'description': 'Number of patients who experience hematoma (bruising) and/or ecchymosis (discoloration of the skin caused by bleeding underneath) at the access site as measured by observation just prior to discharge.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SoftSeal Hemostatic Pad', 'description': 'This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'SoftSeal Hemostatic Pad', 'description': 'This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.1', 'spread': '8.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '47', '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': '51', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-15', 'studyFirstSubmitDate': '2014-11-26', 'resultsFirstSubmitDate': '2016-09-26', 'studyFirstSubmitQcDate': '2014-12-03', 'lastUpdatePostDateStruct': {'date': '2017-01-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-11-15', 'studyFirstPostDateStruct': {'date': '2014-12-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Arterial Bleeding', 'timeFrame': 'Day1', 'description': 'Number of patients who experience arterial bleeding after use of the Softseal hemostatic device and manual compression at the transradial access site as measured by observation.'}, {'measure': 'Incidence of Thrombosis', 'timeFrame': '4 hours post-surgery', 'description': 'Number of patients who experience thrombosis (blood clot) at the access site as measured by ultrasound between 4 hours and 24 hours post-procedure.'}], 'secondaryOutcomes': [{'measure': 'Changes in Circulation, Movement and Sensation', 'timeFrame': 'Day1', 'description': 'Number of patients who experience changes in circulation, movement and sensation in the hand and wrist of the access site as measured by standard of care nursing assessments.'}, {'measure': 'Incidence of Hematoma and/or Ecchymosis', 'timeFrame': 'Day1', 'description': 'Number of patients who experience hematoma (bruising) and/or ecchymosis (discoloration of the skin caused by bleeding underneath) at the access site as measured by observation just prior to discharge.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Radial Artery', 'Hemostasis', 'Angiography'], 'conditions': ['Thrombosis']}, 'descriptionModule': {'briefSummary': 'A recent pilot study conducted at HealthEast found use of manual pressure with the SoftSeal hemostatic pad for 15 minutes was successful in 9 out of 10 people fully anticoagluated using 4 French radial sheath. There was no evidence of radial artery occlusion in this small sample and bleeding was limited to grade 1. This evidence supports a larger retrospective study to confirm these results and define an alternative to the TR band use post radial artery access for cardiac catheterization.\n\nPrimary Objective Determine the incidence of arterial bleeding after real-world use of SoftSeal hemostatic device at a transradial access site with a 4 French system with with manual pressure by compression of the ulnar artery.\n\nSecondary Objective Determine the incidence of thrombosis at the access site in all subjects as presence of thrombus in the radial artery by reverse barbeau test; the incidence of changes in circulation, movement and sensation (CMS) in the hand and wrist on the impacted hand; and the incidence of hematoma and ecchymosis, assessed just prior to discharge.', 'detailedDescription': 'This is a non-randomized, retrospective study to observe the usefulness of SoftSeal. Only patients with radial procedures will be used in this study.\n\nStudy Procedure For patients with a 4 French catheter, SoftSeal will be applied per physician instruction. Current protocol for use includes compression of ulnar artery on the same visit.\n\nAny bleeding observed at the site after manual pressure hold with SoftSeal will constitute a failure to achieve hemostasis patient will be managed per standard of care (SOC).\n\nData Plan Following completion of clinical care we will extract data related to primary and secondary objectives. Data extraction will include documentation of CMS, reverse Barbeau and incidence of hematoma and ecchymosis. Any additional statistical analysis or manuscript writing will be done as part of a separate agreement to be met with the approval of both HaelaTheast Medical Research Institute and Chitogen.\n\nSample Size Calculation Since this is a real-world data analysis project with no control group, there is not a sample size calculation. We believe approximately 50 patients will be enough to provide an understanding of use instructions for the SoftSeal product.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Transradial access site with a 4 French system -\\>18 years old\n\nExclusion Criteria:\n\n* Current oral anti-coagulation therapy\n* Prior participation in this study\n* Positive standard-of-care pregnancy test\n* Investigator discretionary exclusions\n* Patient on dialysis\n* GFR \\<30'}, 'identificationModule': {'nctId': 'NCT02307318', 'briefTitle': 'Heart and Hands Study II: A Retrospective Data Collection & Analysis Project', 'organization': {'class': 'OTHER', 'fullName': 'HealthEast Care System'}, 'officialTitle': 'Heart and Hands Study II: A Retrospective Data Collection & Analysis Project', 'orgStudyIdInfo': {'id': 'H&H-002'}, 'secondaryIdInfos': [{'id': 'Chit-002', 'type': 'OTHER_GRANT', 'domain': 'Chitogen, Inc'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'SoftSeal Hemostatic Pad', 'description': 'This is a single arm study. All patients received the SoftSeal hemostatic pad for compression following elective or urgent coronary angiogram.', 'interventionNames': ['Device: SoftSeal Hemostatic Pad']}], 'interventions': [{'name': 'SoftSeal Hemostatic Pad', 'type': 'DEVICE', 'description': 'Use of SoftSeal hemostatic device at a transradial access site with a 4 French system with with manual pressure by compression of the ulnar artery.', 'armGroupLabels': ['SoftSeal Hemostatic Pad']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55102', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'HealthEast Care System, Inc', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}], 'overallOfficials': [{'name': 'Carmelo Panetta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HealthEast Care System'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HealthEast Care System', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chitogen, Inc.', 'class': 'INDIV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}