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

PHASE3TerminatedINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

February 27, 2006

Primary Completion Date

March 1, 2007

Study Completion Date

March 1, 2007

Conditions
Blood Loss, SurgicalPostoperative Hemorrhage
Interventions
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)

Trial Locations (14)

13086

Berlin

13353

Berlin

23730

Neustadt

28034

Madrid

31008

Pamplona

46010

Valencia

48149

Münster

76307

Karlsbad

L1G 2B9

Oshawa

N9A 1E1

Windsor

H3A 2B4

Montreal

08003

Barcelona

08035

Barcelona

08036

Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY