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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
The primary criterion for efficacy is the percent of patients requiring a blood transfusion anytime in the intra-operative or post-operative period (up to the earlier of Day 7 or discharge)
Anytime in the intra-operative or post-operative period (up to the earlier of Day 7 or discharge)
Bayer Study Director
Study Director
Bayer
United States: Food and Drug Administration
12002
NCT00306150
December 2005
March 2007
Name | Location |
---|---|
Hinsdale, Illinois 60521 | |
Alexandria, Minnesota 56308 | |
Fountain Valley, California 92708 | |
Miami, Florida 33176 | |
Cleveland, Ohio 44195 | |
Philadelphia, Pennsylvania 19104 | |
Nashville, Tennessee 37203-1632 | |
Austin, Texas 78705 | |
Flint, Michigan 48532 | |
Scarborough, Maine 04074 | |
Denver, Colorado | |
Baltimore, Maryland 21287 | |
Charlotte, North Carolina | |
South Burlington, Vermont | |
Tulsa, Oklahoma |