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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Blood Loss, Surgical, Postoperative Hemorrhage

In brief

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.

Key facts

Study ID

NCT00306150

Run by

Bayer

People needed

57

Starts

2005-12-01

Expected to finish

2007-03-01

Last updated by the study team

2014-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Denver, Colorado, United States
• Study site — Miami, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Chicago, Illinois, United States
• Study site — Portland, Maine, United States
• Study site — Baltimore, Maryland, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Rochester, Minnesota, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Cleveland, Ohio, United States
• Study site — Columbus, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Nashville, Tennessee, United States
• Study site — Houston, Texas, United States
• Study site — Burlington, Vermont, United States
• Study site — Ghent, Belgium
• Study site — Leuven, Belgium
• Study site — Nantes, France
• Study site — Nice, France
• Study site — Tübingen, Baden-Wurttemberg, Germany
• Study site — München, Bavaria, Germany
• Study site — Regensburg, Bavaria, Germany

Full record on ClinicalTrials.gov

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