NCT00327379

Effect of Aprotinin on Transfusion Requirements in Patients Undergoing Elective Spinal Fusion Surgery

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Design, 2-Arm Study to Investigate the Effect of Aprotinin on Transfusion Requirements in Patients Undergoing Elective Spinal Fusion Surgery

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the safety and efficacy of aprotinin as compared to placebo, in reducing the need for blood transfusion in adult subjects undergoing elective spinal fusion surgery involving 3 to 7 vertebral levels with instrumentation

Conditions

• Blood Loss, Surgical
• Postoperative Hemorrhage

Interventions

Type	Name	Description
DRUG	Trasylol (Aprotinin, BAYA0128)	Infusion of aprotinin (loading dose of 2 million KIU (Kallikrein Inhibitor Units) followed by 500,000 KIU/hour until the end of surgery)
DRUG	Placebo	Infusion of placebo (loading dose of 2 million KIU (Kallikrein Inhibitor Units) followed by 500,000 KIU/hour until the end of surgery)

Timeline

• Start date: 2006-02-27
• Primary completion: 2007-03-01
• Completion: 2007-03-01
• First posted: 2006-05-18
• Last updated: 2019-06-04

Locations

14 sites across 3 countries: Canada, Germany, Spain