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

PHASE3TerminatedINTERVENTIONAL
Enrollment

57

Participants

Timeline

Start Date

December 31, 2005

Study Completion Date

March 31, 2007

Conditions
Blood Loss, SurgicalPostoperative Hemorrhage
Interventions
DRUG

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.

DRUG

Placebo

Placebo is used according to the description of Arm 1

Trial Locations (37)

3000

Leuven

9000

Ghent

19107

Philadelphia

21224

Baltimore

33125

Miami

36043

Fulda

37232

Nashville

44035

Nantes

55131

Mainz

55905

Rochester

60612

Chicago

60637

Chicago

66421

Homburg

72076

Tübingen

73104

Oklahoma City

77030

Houston

80262

Denver

81377

München

90095

Los Angeles

93053

Regensburg

04102

Portland

48109-0330

Ann Arbor

27599-7065

Chapel Hill

44106-2602

Cleveland

43214-1419

Columbus

15213-2592

Pittsburgh

05401-1420

Burlington

06200

Nice

01307

Dresden

6229 HX

Maastricht

6525 GA

Nijmegen

581 85

Linköping

221 85

Lund

171 76

Stockholm

751 85

Uppsala

CB2 0QQ

Cambridge

NE7 7DN

Newcastle upon Tyne

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY