Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2026-01-03 @ 8:21 PM
Study NCT ID:
NCT00306150
Status:
TERMINATED
Last Update Posted:
2014-12-17
First Post:
2006-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Aprotinin on Transfusion Requirements in Patients Undergoing Radical or Total Cystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016063', 'term': 'Blood Loss, Surgical'}, {'id': 'D019106', 'term': 'Postoperative Hemorrhage'}], 'ancestors': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007431', 'term': 'Intraoperative Complications'}, {'id': 'D011183', 'term': 'Postoperative Complications'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007611', 'term': 'Aprotinin'}], 'ancestors': [{'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-16', 'studyFirstSubmitDate': '2006-03-21', 'studyFirstSubmitQcDate': '2006-03-21', 'lastUpdatePostDateStruct': {'date': '2014-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary criterion for efficacy is the percent of patients requiring a blood transfusion anytime in the intra-operative or post-operative period (up to the earlier of Day 7 or discharge)', 'timeFrame': 'Anytime in the intra-operative or post-operative period (up to the earlier of Day 7 or discharge)'}], 'secondaryOutcomes': [{'measure': 'The number of units of blood or packed red cells transfused. There will be an analysis for the combination of autologous and allogenic transfusion and for allogenic alone', 'timeFrame': 'Intra- and postoperative'}, {'measure': 'The number of units of blood or packed red cells transfused per patient requiring transfusion', 'timeFrame': 'Intra- and postoperative'}, {'measure': 'The intraoperative blood loss determined as follow: a) by surgeon estimate b) summing weight of the blood in gauze and other materials and the suction drainage volume', 'timeFrame': 'Intraoperative'}, {'measure': 'The drainage volume (in milliliters) from the operative site', 'timeFrame': 'In the first 8 hours post-operatively, and daily total drainage until removal of drains or until discharge, whichever comes first'}, {'measure': 'Transfusion of platelets, colloids, plasma and number of patients requiring these products', 'timeFrame': 'Intra- and postoperative'}, {'measure': 'The change from preoperative hemoglobin concentration to postoperative hemoglobin concentration', 'timeFrame': 'Obtained in the morning of postoperative Day 3, or, if transfused earlier, prior to transfusion'}, {'measure': 'Surgeon s assessment of the degree to which bleeding obscures his/her view of the surgical field, relative to past, similar procedures', 'timeFrame': 'Intraoperative'}, {'measure': 'Changes in blood markers related to inflammation and blood coagulation; baseline until Discharge or day 7', 'timeFrame': 'Several measurements from baseline up to 6 weeks'}, {'measure': 'Time to discontinuing of mechanical ventilation', 'timeFrame': 'Not specifed'}, {'measure': 'Changes in FEV1', 'timeFrame': 'Baseline until Discharge or day7'}, {'measure': 'Changes in the patients health related quality of life (HRQoL) (at baseline and 6+-2 weeks post surgery) using the Functional Assessment Cancer Therapy for patients with Bladder cancer (FACT-Bl) questionnaire', 'timeFrame': 'At baseline and 6+-2 weeks post surgery'}]}, 'conditionsModule': {'keywords': ['Prevention of blood loss', 'Blood Loss, Surgical', 'Blood Loss, Postoperative'], 'conditions': ['Blood Loss, Surgical', 'Postoperative Hemorrhage']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.clinicaltrialsregister.eu', 'label': 'Click here and search for information of Bayer products for Europe'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess if aprotinin (BAYA0128), given intravenously during your surgery, is safe and can help reduce the need for a blood transfusion during bladder surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects 18 years of age and older\n* Subjects requiring elective radical or total cystectomy for bladder cancer\n* Documented, signed, dated informed consent obtained prior to any study specific procedures being performed\n\nExclusion Criteria:\n\n* Subjects with previous exposure to aprotinin in the last 6 months or with a known or suspected allergy to aprotinin\n* Subjects with sepsis or undergoing laparoscopic surgery\n* Subjects with impaired renal function (serum creatinine \\>2.5 mg/dL or 221 micromoles/liter)\n* Subjects with a history of bleeding diathesis, deep vein thrombosis or pulmonary embolism or known coagulation factor deficiency. Based on the investigator's opinion of any active significant medical illness the subject may have\n* Subjects who refuse to receive allogenic blood products or whose preoperative red blood cell volume is so low that a blood transfusion would be likely to be given perioperatively (preoperative hematocrit of \\<24% or hemoglobin of \\<8 g/dl)\n* Subjects who have participated in an investigational drug study within the past 30 days\n* Subjects who are pregnant or breastfeeding or women of childbearing potential in whom the possibility of pregnancy cannot be excluded by a negative pregnancy test and who are not using a reliable method of contraception\n* Planned use of other antifibrinolytic agents, e.g. aminocaproic acid or tranexamic acid\n* Subjects on chronic anticoagulant treatment with warfarin that cannot be temporarily discontinued for the surgical procedure (as per local practices)"}, 'identificationModule': {'nctId': 'NCT00306150', 'briefTitle': 'Efficacy and Safety of Aprotinin on Transfusion Requirements in Patients Undergoing Radical or Total Cystectomy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Multi-center, Randomized, Double Blind, Placebo Controlled Study to Investigate the Efficacy and Safety of Aprotinin on Transfusion Requirements in Patients With Bladder Cancer Undergoing Radical or Total Cystectomy.', 'orgStudyIdInfo': {'id': '12002'}, 'secondaryIdInfos': [{'id': '2005-004055-35', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'interventionNames': ['Drug: Trasylol (Aprotinin, BAYA0128)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 2', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Trasylol (Aprotinin, BAYA0128)', 'type': 'DRUG', 'description': 'Subjects will be randomized to receive an infusion of aprotinin (a test dose followed by a loading dose of 2 million KIU before skin incision followed by 500,000 KIU/hour until the end of surgery) or matching placebo. The maximal dose of aprotinin, that can be administered is 7,000,000 KIU, regardless of the duration of the operation. When a total of 7 million has been reached the administration of aprotinin must be discontinued.', 'armGroupLabels': ['Arm 1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo is used according to the description of Arm 1', 'armGroupLabels': ['Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80262', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33125', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': 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