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

NCT00327379 | Terminated Phase 3

• 2 other identifiers: 117992005-003999-38
• Study Type: interventional
• Target: 54
• Locations: 3 countries
• Sites: 14

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

Keywords

Bloodloss; Transfusion Requirements in Patients Undergoing Elective Spinal Fusion Surgery

Outcome Measures

Primary Outcomes (1)

• Percent of patients requiring a blood transfusion (blood or packed red blood cells, autologous or allogenic)

  anytime in the intra-operative or postoperative period (up to the earlier of Day 7 or discharge).

Secondary Outcomes (11)

• The percent of patients receiving an allogenic transfusion of blood or packed red cells during surgery and up to the earlier of Day 7 or discharge

  surgery to discharge

• The percent of patients who did and did not predonate blood receiving an allogenic transfusion of blood or packed red cells during surgery and up to the earlier of Day 7 or discharge

  surgery to discharge

• The number of units of blood or packed red cells transfused. There will be analyses for the combination of autologous and allogenic transfusion and for allogenic alone

  surgery to discharge

• The number of units of blood or packed red cells transfused per patient requiring transfusion

  surgery to discharge

• Drainage (in milliliters) from the operative site in the first 8 hours postoperatively, and total drainage until removal of drains or until hospital discharge (whichever is earlier)

  surgery to discharge

Study Arms (2)

Arm 1

EXPERIMENTAL

Drug: Trasylol (Aprotinin, BAYA0128)

Arm 2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Trasylol (Aprotinin, BAYA0128) 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 1

Placebo DRUG

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

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Bayer: lead

Study Sites (14)

Unknown Facility

Oshawa, Ontario, L1G 2B9, Canada

Location

Unknown Facility

Windsor, Ontario, N9A 1E1, Canada

Location

Unknown Facility

Montreal, Quebec, H3A 2B4, Canada

Location

Unknown Facility

Karlsbad, Baden-Wurttemberg, 76307, Germany

Location

Unknown Facility

Münster, North Rhine-Westphalia, 48149, Germany

Location

Unknown Facility

Neustadt, Schleswig-Holstein, 23730, Germany

Location

Unknown Facility

Berlin, 13086, Germany

Location

Unknown Facility

Berlin, 13353, Germany

Location

Unknown Facility

Barcelona, 08003, Spain

Location

Unknown Facility

Barcelona, 08035, Spain

Location

Unknown Facility

Barcelona, 08036, Spain

Location

Unknown Facility

Madrid, 28034, Spain

Location

Unknown Facility

Pamplona, 31008, Spain

Location

Unknown Facility

Valencia, 46010, Spain

Location

Related Links

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

MeSH Terms

Conditions

Blood Loss, Surgical; Postoperative Hemorrhage

Interventions

Aprotinin

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications; Postoperative Complications

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2006
• First Posted: May 18, 2006
• Study Start: February 27, 2006
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: June 4, 2019

Record last verified: 2019-06

Locations

ES (6); CA (3); DE (5)