NCT00668031

Effect of Aprotinin on Transfusion Requirements and Blood Loss in Patients Undergoing Elective Primary Total Hip Replacement

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Design, 2-Arm Study to Investigate the Effect of Aprotinin on Transfusion Requirements and Blood Loss in Patients Undergoing Elective Primary Total Hip Replacement Surgery

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 359 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess if aprotinin (BAY A0128), given intravenously during surgery, is safe and can help reduce the amount of bleeding and the need for a blood transfusion during hip replacement surgery. Patients undergoing major surgery are at risk for significant blood loss. Because of this, there is a need for drugs that will help slow the amount of bleeding during surgery.

Conditions

• Blood Loss, Surgical

Interventions

Type	Name	Description
DRUG	Trasylol (Aprotinin, BAYA0128)	A loading dose IV infusion of 2,000,000 KIU (200 mL) followed by 500,000 KIU (50 mL) IV per hour until the end of surgery of aprotinin using an IV infusion pump
DRUG	Placebo	A loading dose IV infusion of 2,000,000 KIU (200 mL) followed by 500,000 KIU (50 mL) IV per hour until the end of surgery of of placebo using an IV infusion pump

Timeline

• Start date: 2005-02-01
• Primary completion: 2006-01-01
• Completion: 2006-01-01
• First posted: 2008-04-28
• Last updated: 2014-12-30

Locations

40 sites across 3 countries: United States, Canada, Puerto Rico