Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-01-01 @ 5:58 AM
Study NCT ID:
NCT00814333
Status:
TERMINATED
Last Update Posted:
2016-01-15
First Post:
2008-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial Comparing Outcomes With Merocel Packing or Thrombin-JMI for Anterior Epistaxis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004844', 'term': 'Epistaxis'}], 'ancestors': [{'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013917', 'term': 'Thrombin'}], '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': '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': 'ksykes@kumc.edu', 'phone': '913-588-7154', 'title': 'Kevin Sykes, PhD', 'organization': 'University of Kansas Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Merocel Pack', 'description': 'Standard of care for persons being treated for epistaxis.\n\nMerocel pack: 8 cm pack, inserted within the affected side between the septum and inferior turbinate via bayonet forceps', 'otherNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Thrombin-JMI', 'description': 'Thrombin-JMI: 5,000 IU, to nasal mucosa via syringe spray applicator', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cessation of Epistaxis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Merocel Pack', 'description': 'Standard of care for persons being treated for epistaxis.\n\nMerocel pack: 8 cm pack, inserted within the affected side between the septum and inferior turbinate via bayonet forceps'}, {'id': 'OG001', 'title': 'Thrombin-JMI', 'description': 'Thrombin-JMI: 5,000 IU, to nasal mucosa via syringe spray applicator'}], 'timeFrame': 'baseline, day 4-6', 'reportingStatus': 'POSTED', 'populationDescription': 'No participants started treatment on this study. Study was closed before any study related procedures were administered.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Merocel Pack', 'description': 'Standard of care for persons being treated for epistaxis.\n\nMerocel pack: 8 cm pack, inserted within the affected side between the septum and inferior turbinate via bayonet forceps'}, {'id': 'FG001', 'title': 'Thrombin-JMI', 'description': 'Thrombin-JMI: 5,000 IU, to nasal mucosa via syringe spray applicator'}], 'periods': [{'title': 'Enrollment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Merocel Pack', 'description': 'Standard of care for persons being treated for epistaxis.\n\nMerocel pack: 8 cm pack, inserted within the affected side between the septum and inferior turbinate via bayonet forceps'}, {'id': 'BG001', 'title': 'Thrombin-JMI', 'description': 'Thrombin-JMI: 5,000 IU, to nasal mucosa via syringe spray applicator'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'title': '<=18 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Between 18 and 65 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Gender', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Product supplier change - bought out. Unable to enroll patients.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-10', 'studyFirstSubmitDate': '2008-12-23', 'resultsFirstSubmitDate': '2015-12-10', 'studyFirstSubmitQcDate': '2008-12-23', 'lastUpdatePostDateStruct': {'date': '2016-01-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-12-10', 'studyFirstPostDateStruct': {'date': '2008-12-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cessation of Epistaxis', 'timeFrame': 'baseline, day 4-6'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['epistaxis'], 'conditions': ['Epistaxis']}, 'descriptionModule': {'briefSummary': 'Epistaxis is a common problem among people of all ages and backgrounds. However, occasionally epistaxis can be severe enough to require emergency room admission. Among the treatment options for epistaxis, nasal packing is the most common approach. This approach requires a return visit to the clinic for removal of the packing. Additionally, there is a great deal of pain during the insertion and removal of this packing. This study aims to justify the further investigation of thrombin as a potential treatment approach for these patients. Thrombin could provide a treatment approach that reduces pain and eliminates the need for a return visit to the clinic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English speaking adults that have failed first line therapy for anterior epistaxis in the ER or the hospital\n\nExclusion Criteria:\n\n* Non-english speaking patients\n* Patients with bleeding disorders\n* Known pregnant women or women that think they may be pregnant\n* Patients with a know presence of antibodies to bovine thrombin preparations\n* Patients that currently have or are known to have a history of systemic skin condition or rash such as eczema or psoriasis\n* Patients found to have posterior epistaxis\n* Patients requiring a surrogate for medical decisions'}, 'identificationModule': {'nctId': 'NCT00814333', 'briefTitle': 'Trial Comparing Outcomes With Merocel Packing or Thrombin-JMI for Anterior Epistaxis', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'A Randomized Controlled Trial Comparing Outcomes in Patients Treated With Merocel Packing or Thrombin-JMI for Anterior Epistaxis', 'orgStudyIdInfo': {'id': '11564'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Thrombin-JMI', 'interventionNames': ['Drug: Thrombin-JMI']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Merocel pack', 'interventionNames': ['Drug: Merocel pack']}], 'interventions': [{'name': 'Thrombin-JMI', 'type': 'DRUG', 'description': '5,000 IU, to nasal mucosa via syringe spray applicator', 'armGroupLabels': ['1']}, {'name': 'Merocel pack', 'type': 'DRUG', 'description': '8 cm pack, inserted within the affected side between the septum and inferior turbinate via bayonet forceps', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'overallOfficials': [{'name': 'Keith Sale, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'King Pharmaceuticals is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor & Vice Chairman, Otolaryngology', 'investigatorFullName': 'Keith Sale, MD', 'investigatorAffiliation': 'University of Kansas Medical Center'}}}}