Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-02-20 @ 10:58 PM
Study NCT ID:
NCT02752256
Status:
COMPLETED
Last Update Posted:
2019-07-05
First Post:
2016-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Thrombolytic Care During Inter-hospital Transfer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010959', 'term': 'Tissue Plasminogen Activator'}], 'ancestors': [{'id': 'D012697', 'term': 'Serine Endopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D057057', 'term': 'Serine Proteases'}, {'id': 'D010960', 'term': 'Plasminogen Activators'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'brett-faine@uiowa.edu', 'phone': '319-384-6800', 'title': 'Brett Faine', 'organization': 'University of Iowa Hospitals and Clinics'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'In-hospital mortality, serious adverse events, adverse events up to 90 days', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention/Transfer', 'description': 'Patients who are transferred via air ambulance to a comprehensive stroke center\n\nTissue Plasminogen Activator', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'deathsNumAffected': 2, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Patients presenting directly to the comprehensive stroke center\n\nTissue Plasminogen Activator', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With a rtPA Protocol Violation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention/Transfer', 'description': 'Patients who are transferred via air ambulance to a comprehensive stroke center\n\nTissue Plasminogen Activator'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients presenting directly to the comprehensive stroke center\n\nTissue Plasminogen Activator'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours', 'description': 'Protocol violations can include any of the following recorded outcomes: inaccurate dosing or preparation at the outside hospital, uncontrolled blood pressure before and during the flight, unnecessary medication administration before and during the flight, intracranial bleeding, and angioedema', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Time to rtPA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention/Transfer', 'description': 'Patients who are transferred via air ambulance to a comprehensive stroke center\n\nTissue Plasminogen Activator'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients presenting directly to the comprehensive stroke center\n\nTissue Plasminogen Activator'}], 'classes': [{'categories': [{'measurements': [{'value': '74.5', 'spread': '34.2', 'groupId': 'OG000'}, {'value': '60', 'spread': '31.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention/Transfer', 'description': 'Patients who are transferred via air ambulance to a comprehensive stroke center\n\nTissue Plasminogen Activator'}, {'id': 'FG001', 'title': 'Control', 'description': 'Patients presenting directly to the comprehensive stroke center\n\nTissue Plasminogen Activator'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention/Transfer', 'description': 'Patients who are transferred via air ambulance to a comprehensive stroke center\n\nTissue Plasminogen Activator'}, {'id': 'BG001', 'title': 'Control', 'description': 'Patients presenting directly to the comprehensive stroke center\n\nTissue Plasminogen Activator'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67', 'spread': '14.3', 'groupId': 'BG000'}, {'value': '65', 'spread': '22.2', 'groupId': 'BG001'}, {'value': '66', 'spread': '18.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'NIH Stroke Scale/Score (NIHSS)', 'classes': [{'categories': [{'measurements': [{'value': '8', 'spread': '8', 'groupId': 'BG000'}, {'value': '6', 'spread': '5', 'groupId': 'BG001'}, {'value': '7', 'spread': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Minimum 0 (good clinical outcome), Maximum 42 (poor clinical outcome)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-09-11', 'size': 40768, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-04-11T13:08', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-28', 'studyFirstSubmitDate': '2016-04-18', 'resultsFirstSubmitDate': '2019-01-11', 'studyFirstSubmitQcDate': '2016-04-22', 'lastUpdatePostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-06-28', 'studyFirstPostDateStruct': {'date': '2016-04-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With a rtPA Protocol Violation', 'timeFrame': '24 hours', 'description': 'Protocol violations can include any of the following recorded outcomes: inaccurate dosing or preparation at the outside hospital, uncontrolled blood pressure before and during the flight, unnecessary medication administration before and during the flight, intracranial bleeding, and angioedema'}], 'secondaryOutcomes': [{'measure': 'Average Time to rtPA', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['tissue plasminogen activator'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '30037651', 'type': 'DERIVED', 'citation': 'Faine BA, Dayal S, Kumar R, Lentz SR, Leira EC. Helicopter "Drip and Ship" Flights Do Not Alter the Pharmacological Integrity of rtPA. J Stroke Cerebrovasc Dis. 2018 Oct;27(10):2720-2724. doi: 10.1016/j.jstrokecerebrovasdis.2018.05.049. Epub 2018 Jul 20.'}]}, 'descriptionModule': {'briefSummary': 'Evaluation of ischemic stroke patients receiving tissue plasminogen activator (rtPA) during air ambulance transfer', 'detailedDescription': 'The purpose of our study is to evaluate the effect of air ambulance transport on patients presenting with an ischemic stroke and receive tissue plasminogen activator (rtPA). Primary outcome will be the evaluation of air ambulance transfer and if it leads to protocol violations or significant delays in therapy. Protocol violations include inaccurate dosing or preparation at the outside hospital, uncontrolled blood pressure before and during the flight, unnecessary medication administration before and during the flight and adverse events (intracranial bleeding, allergic reaction) associated with transfer process. Additional evaluation will include the effects of vibration of the air ambulance and its effects on the lytic activity of rtPA. rtPA is not supposed to be significantly agitated after it is prepared in solution and there is significant vibration and agitation during air ambulance transfer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All acute ischemic stroke patients who receive rtPA and transferred to our institution via our air ambulance service or present directly to our ED', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who received tissue plasminogen activator for acute ischemic stroke\n* presented directly to comprehensive stroke center or were transferred by our air ambulance service\n\nExclusion Criteria:\n\n* Transferred by another air ambulance service or ground ambulance'}, 'identificationModule': {'nctId': 'NCT02752256', 'briefTitle': 'Thrombolytic Care During Inter-hospital Transfer', 'organization': {'class': 'OTHER', 'fullName': 'University of Iowa'}, 'officialTitle': 'Quality and Effectiveness of Thrombolytic Care During Inter-hospital Transfer ("Drip-Ship") With Air Ambulance Services', 'orgStudyIdInfo': {'id': 'IRB:201507803'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intervention/Transfer', 'description': 'Patients who are transferred via air ambulance to a comprehensive stroke center', 'interventionNames': ['Drug: Tissue Plasminogen Activator']}, {'label': 'Control', 'description': 'Patients presenting directly to the comprehensive stroke center', 'interventionNames': ['Drug: Tissue Plasminogen Activator']}], 'interventions': [{'name': 'Tissue Plasminogen Activator', 'type': 'DRUG', 'armGroupLabels': ['Control', 'Intervention/Transfer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospitals and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Iowa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Pharmacy Specialist', 'investigatorFullName': 'Brett A Faine', 'investigatorAffiliation': 'University of Iowa'}}}}