Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-04-19 @ 1:25 AM
Study NCT ID:
NCT01982760
Status:
TERMINATED
Last Update Posted:
2023-08-16
First Post:
2013-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
DDAVP in the Reduction of Post-operative Ecchymosis in Rhinoplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004438', 'term': 'Ecchymosis'}, {'id': 'D004487', 'term': 'Edema'}], 'ancestors': [{'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003894', 'term': 'Deamino Arginine Vasopressin'}], 'ancestors': [{'id': 'D001127', 'term': 'Arginine Vasopressin'}, {'id': 'D014667', 'term': 'Vasopressins'}, {'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bguyuron@guyuron.com', 'phone': '440-461-7999', 'title': 'Dr. Bahman Guyuron', 'organization': 'Case School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'AE data not collected', 'description': 'No AE data collected since study was terminated', 'eventGroups': [{'id': 'EG000', 'title': 'DDAVP', 'description': 'Arm receiving DDAVP prior to the operation. Drug is administered intravenously at .3mcg per kg, over 30 minutes prior to the operation.\n\nDDAVP: Patients Receiving DDAVP prior to operation', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'No DDAVP', 'description': 'Patients Will not receive DDAVP prior to Rhinoplasty', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Reduction in Ecchymosis and Swelling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DDAVP', 'description': 'Arm receiving DDAVP prior to the operation. Drug is administered intravenously at .3mcg per kg, over 30 minutes prior to the operation.\n\nDDAVP: Patients Receiving DDAVP prior to operation'}, {'id': 'OG001', 'title': 'No DDAVP', 'description': 'Patients Will not receive DDAVP prior to Rhinoplasty'}], 'timeFrame': 'surgery to 8 days post-operatively', 'description': 'Photographs taken preoperatively at 1 day and 8 days post-operatively will be analyzed for bruising', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected'}, {'type': 'SECONDARY', 'title': 'Patient Behavior Factors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DDAVP', 'description': 'Arm receiving DDAVP prior to the operation. Drug is administered intravenously at .3mcg per kg, over 30 minutes prior to the operation.\n\nDDAVP: Patients Receiving DDAVP prior to operation'}, {'id': 'OG001', 'title': 'No DDAVP', 'description': 'Patients Will not receive DDAVP prior to Rhinoplasty'}], 'timeFrame': 'Surgery to 3 weeks post-operatively', 'description': 'Looking at the time it takes for patients to feel comfortable wearing makeup, going out in public, and returning to work', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DDAVP', 'description': 'Arm receiving DDAVP prior to the operation. Drug is administered intravenously at .3mcg per kg, over 30 minutes prior to the operation.\n\nDDAVP: Patients Receiving DDAVP prior to operation'}, {'id': 'FG001', 'title': 'No DDAVP', 'description': 'Patients Will not receive DDAVP prior to Rhinoplasty'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'DDAVP', 'description': 'Arm receiving DDAVP prior to the operation. Drug is administered intravenously at .3mcg per kg, over 30 minutes prior to the operation.\n\nDDAVP: Patients Receiving DDAVP prior to operation'}, {'id': 'BG001', 'title': 'No DDAVP', 'description': 'Patients Will not receive DDAVP prior to Rhinoplasty'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'No patients were enrolled in the control arm as the study was terminated.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2015-06-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-26', 'studyFirstSubmitDate': '2013-11-05', 'resultsFirstSubmitDate': '2023-07-07', 'studyFirstSubmitQcDate': '2013-11-05', 'lastUpdatePostDateStruct': {'date': '2023-08-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-26', 'studyFirstPostDateStruct': {'date': '2013-11-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-06-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in Ecchymosis and Swelling', 'timeFrame': 'surgery to 8 days post-operatively', 'description': 'Photographs taken preoperatively at 1 day and 8 days post-operatively will be analyzed for bruising'}], 'secondaryOutcomes': [{'measure': 'Patient Behavior Factors', 'timeFrame': 'Surgery to 3 weeks post-operatively', 'description': 'Looking at the time it takes for patients to feel comfortable wearing makeup, going out in public, and returning to work'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Rhinoplasty', 'Ecchymosis', 'Edema'], 'conditions': ['Postoperative Ecchymosis']}, 'descriptionModule': {'briefSummary': 'This is study looking at the use of a medication, Desmopressin acetate (DDAVP), to reduce bleeding, swelling, and bruising in patients undergoing cosmetic nose surgery. DDAVP is a drug used in patients with bleeding disorders. It works by activating molecules in the blood stream called platelets that promote clotting. In the study, participants who are have cosmetic nose surgery (rhinoplasty) will be randomly assigned to receive or not receive medication. Photographs taken before and shortly after surgery will be evaluated for the amount of bruising and swelling. Patients with heart, lung, kidney, or liver problems are not eligible to participate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing Rhinoplasty where nasal bone osteotomy is necessary\n\nExclusion Criteria:\n\n* Heart Disease\n* Renal Disease with decreased GFR\n* Liver Disease'}, 'identificationModule': {'nctId': 'NCT01982760', 'briefTitle': 'DDAVP in the Reduction of Post-operative Ecchymosis in Rhinoplasty', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals Cleveland Medical Center'}, 'officialTitle': 'A Prospective Randomized Trial for the Use of DDAVP in the Reduction of Post-operative Ecchymosis in Rhinoplasty.', 'orgStudyIdInfo': {'id': '07-10-21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DDAVP', 'description': 'Arm receiving DDAVP prior to the operation. Drug is administered intravenously at .3mcg per kg, over 30 minutes prior to the operation.', 'interventionNames': ['Drug: DDAVP']}, {'type': 'NO_INTERVENTION', 'label': 'No DDAVP', 'description': 'Patients Will not receive DDAVP prior to Rhinoplasty'}], 'interventions': [{'name': 'DDAVP', 'type': 'DRUG', 'otherNames': ['Desmopressin'], 'description': 'Patients Receiving DDAVP prior to operation', 'armGroupLabels': ['DDAVP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44124', 'city': 'Lyndhurst', 'state': 'Ohio', 'country': 'United States', 'facility': 'Lyndhurst Surgery Center', 'geoPoint': {'lat': 41.52005, 'lon': -81.48873}}], 'overallOfficials': [{'name': 'Bahman Guyuron, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals Cleveland Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}