NCT00306150

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

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.

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Blood Loss, Surgical
• Postoperative Hemorrhage

Interventions

Type	Name	Description
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

Timeline

• Start date: 2005-12-01
• Completion: 2007-03-01
• First posted: 2006-03-23
• Last updated: 2014-12-17

Locations

37 sites across 7 countries: United States, Belgium, France, Germany, Netherlands, Sweden, United Kingdom