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.

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)