Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-02-26 @ 8:11 PM
Study NCT ID:
NCT00861367
Status:
WITHDRAWN
Last Update Posted:
2024-03-19
First Post:
2009-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Double-blind Study for the Use of Aspirin During Transurethral Surgery of the Bladder or the Prostate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016063', 'term': 'Blood Loss, Surgical'}, {'id': 'D007431', 'term': 'Intraoperative Complications'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'difficult enrollment, focus of study no longer of interest', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-18', 'studyFirstSubmitDate': '2009-03-12', 'studyFirstSubmitQcDate': '2009-03-12', 'lastUpdatePostDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood loss', 'timeFrame': 'intraoperative, 6 hours post op, 3 days postop'}], 'secondaryOutcomes': [{'measure': 'Reoperation rates', 'timeFrame': 'during hospitalization'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['aspirin', 'blood loss', 'transurethral surgery'], 'conditions': ['Blood Loss, Surgical', 'Intraoperative Complications', 'Re-operation Rates in Patients With Aspirin Treatment']}, 'descriptionModule': {'briefSummary': 'Aspirin is very common in older patients. Therefore many of the investigators patients have aspirin. The aim of the study is to proof that Transurethral Surgery of the bladder or the prostate can be performed with aspirin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Transurethral surgery of the bladder or prostate, informed consent, age over 18\n\nExclusion Criteria:\n\n* Oral anticoagulation,'}, 'identificationModule': {'nctId': 'NCT00861367', 'briefTitle': 'Prospective Double-blind Study for the Use of Aspirin During Transurethral Surgery of the Bladder or the Prostate', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Prospektive Doppel-Blind-randomisierte Studie Zur Verwendung Von Aspirin Bei Transurethralen Operationen', 'orgStudyIdInfo': {'id': '05/08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'aspirin 100mg', 'interventionNames': ['Drug: transurethral surgery with or without aspirin']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'empty capsule', 'interventionNames': ['Drug: transurethral surgery with or without aspirin']}], 'interventions': [{'name': 'transurethral surgery with or without aspirin', 'type': 'DRUG', 'otherNames': ['Asprin cardio 100mg'], 'description': 'aspirin 100mg once a day, transurethral surgery with or without aspirin', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4410', 'city': 'Liestal', 'country': 'Switzerland', 'facility': 'Urologische Universitätsklinik Basel-Liestal', 'geoPoint': {'lat': 47.48455, 'lon': 7.73446}}], 'overallOfficials': [{'name': 'Thomas C Gasser, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Urology, Liestal'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}