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

NCT ID: NCT00327379

Last Updated: 2019-06-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-27
• Study Completion Date: 2007-03-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

Trasylol (Aprotinin, BAYA0128)

Intervention Type: DRUG

Infusion of aprotinin (loading dose of 2 million KIU (Kallikrein Inhibitor Units) followed by 500,000 KIU/hour until the end of surgery)

Arm 2

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Infusion of placebo (loading dose of 2 million KIU (Kallikrein Inhibitor Units) followed by 500,000 KIU/hour until the end of surgery)

Interventions

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)

Intervention Type: 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)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subjects requiring elective spinal fusion surgery involving 3 to 7 vertebral levels with instrumentation. One vertebral level is defined as encompassing two vertebral bodies and one inter-vertebral disc space, so that a contiguous spinal fusion involving 3 vertebral levels would include 4 vertebral bodies and 3 inter-vertebral disc spaces.

Exclusion Criteria

• Subjects with previous exposure to aprotinin in the last 6 months. If the subject has undergone cardiac surgery in the last 6 months, all attempts should be made to ascertain if aprotinin was administered during cardiac surgery. If no records are available, or if the subject received aprotinin, the subject should be excluded.- Subjects with a known or suspected allergy to aprotinin.
• Subjects with sepsis or a known bone infection.- Subjects with known bone malignancy.
• Subjects with a creatinine clearance less than 30mL/min as calculated by the Cockcroft-Gault formula.
• Subjects with a history of bleeding diathesis or known coagulation factor deficiency.
• Subjects with failure of a major organ system or any active significant medical illness that in the opinion of the Investigator is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study
• Subjects who refuse to receive allogenic blood products for religious or other reasons.
• Subjects whose preoperative red blood cell volume is so low that a blood transfusion would be likely to be given perioperatively (preoperative hematocrit or hemoglobin values <24% or <8 g/dl, respectively).
• Subjects who have participated in an investigational drug study within the past 30 days
• Subjects with a history of deep vein thrombosis or pulmonary embolism.
• Subjects who are pregnant or breast feeding.
• Women of childbearing potential in whom the possibility of pregnancy cannot be excluded by a negative serum pregnancy test at screening.
• Women of childbearing potential who are not using a reliable method of contraception.
• Planned use of other antifibrinolytic agents.
• Subjects on chronic anticoagulant treatment with Vit K antagonists that cannot be temporarily discontinued for the surgical procedure (as per local practices).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Oshawa, Ontario, Canada

Windsor, Ontario, Canada

Montreal, Quebec, Canada

Karlsbad, Baden-Wurttemberg, Germany

Münster, North Rhine-Westphalia, Germany

Neustadt, Schleswig-Holstein, Germany

Berlin, , Germany

Berlin, , Germany

Barcelona, , Spain

Barcelona, , Spain

Barcelona, , Spain

Madrid, , Spain

Pamplona, , Spain

Valencia, , Spain

Countries

Canada; Germany; Spain

Related Links

http://www.clinicaltrialsregister.eu/

Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Other Identifiers

2005-003999-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

11799

Identifier Type: -

Identifier Source: org_study_id