Efficacy and Safety of Aprotinin on Transfusion Requirements in Patients Undergoing Radical or Total Cystectomy
NCT ID: NCT00306150
Last Updated: 2014-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
57 participants
INTERVENTIONAL
2005-12-31
2007-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 1
Trasylol (Aprotinin, BAYA0128)
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.
Arm 2
Placebo
Placebo is used according to the description of Arm 1
Interventions
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Trasylol (Aprotinin, BAYA0128)
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.
Placebo
Placebo is used according to the description of Arm 1
Eligibility Criteria
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Inclusion Criteria
* Subjects requiring elective radical or total cystectomy for bladder cancer
* Documented, signed, dated informed consent obtained prior to any study specific procedures being performed
Exclusion Criteria
* Subjects with sepsis or undergoing laparoscopic surgery
* Subjects with impaired renal function (serum creatinine \>2.5 mg/dL or 221 micromoles/liter)
* 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
* 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)
* Subjects who have participated in an investigational drug study within the past 30 days
* 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
* Planned use of other antifibrinolytic agents, e.g. aminocaproic acid or tranexamic acid
* Subjects on chronic anticoagulant treatment with warfarin that cannot be temporarily discontinued for the surgical procedure (as per local practices)
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Los Angeles, California, United States
Denver, Colorado, United States
Miami, Florida, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Portland, Maine, United States
Baltimore, Maryland, United States
Ann Arbor, Michigan, United States
Rochester, Minnesota, United States
Chapel Hill, North Carolina, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Oklahoma City, Oklahoma, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Burlington, Vermont, United States
Ghent, , Belgium
Leuven, , Belgium
Nantes, , France
Nice, , France
Tübingen, Baden-Wurttemberg, Germany
München, Bavaria, Germany
Regensburg, Bavaria, Germany
Fulda, Hesse, Germany
Mainz, Rhineland-Palatinate, Germany
Homburg, Saarland, Germany
Dresden, Saxony, Germany
Maastricht, , Netherlands
Nijmegen, , Netherlands
Linköping, , Sweden
Lund, , Sweden
Stockholm, , Sweden
Uppsala, , Sweden
Cambridge, Cambridgeshire, United Kingdom
Newcastle upon Tyne, Tyne and Wear, United Kingdom
Countries
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Related Links
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Click here and search for information of Bayer products for Europe
Other Identifiers
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12002
Identifier Type: -
Identifier Source: org_study_id
2005-004055-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id