Efficacy and Safety of Aprotinin on Transfusion Requirements in Patients Undergoing Radical or Total Cystectomy

Inclusion Criteria: * Subjects 18 years of age and older * 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 previous exposure to aprotinin in the last 6 months or with a known or suspected allergy to aprotinin * 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)