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

• Status: Terminated
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Aprotinin

Criteria

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)