104
Participants
Start Date
December 31, 2005
Study Completion Date
March 31, 2007
Trasylol (Aprotinin, BAYA0128)
"Subjects successfully meeting all screening criteria 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 aprotinin was supplied in infusion vials of 200mL solution containing 2,000,000 KIU (10,000 KIU/mL) in 0.9% sodium chloride.~Subjects will be stratified into one of the 4 following strata:~* Stratum 1: complete primary pneumonectomy~* Stratum II: decortication or completion pneumonectomy~* Stratum III: esophagectomy by transhiatal approach~* Stratum IV: esophagectomy by transthoracic approach"
Placebo
Placebo solution was supplied in identical vials and will consist of 200mL of 0.9% sodium chloride.
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Lead Sponsor
Bayer
INDUSTRY