57
Participants
Start Date
December 31, 2005
Study Completion Date
March 31, 2007
Trasylol (Aprotinin, BAYA0128)
Subjects will be randomized to receive an infusion of aprotinin (a test dose followed by a loading dose of 2 million KIU before skin incision followed by 500,000 KIU/hour until the end of surgery) or matching placebo. The maximal dose of aprotinin, that can be administered is 7,000,000 KIU, regardless of the duration of the operation. When a total of 7 million has been reached the administration of aprotinin must be discontinued.
Placebo
Placebo is used according to the description of Arm 1
Leuven
Ghent
Philadelphia
Baltimore
Miami
Fulda
Nashville
Nantes
Mainz
Rochester
Chicago
Chicago
Homburg
Tübingen
Oklahoma City
Houston
Denver
München
Los Angeles
Regensburg
Portland
Ann Arbor
Chapel Hill
Cleveland
Columbus
Pittsburgh
Burlington
Nice
Dresden
Maastricht
Nijmegen
Linköping
Lund
Stockholm
Uppsala
Cambridge
Newcastle upon Tyne
Lead Sponsor
Bayer
INDUSTRY