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

Condition(s) targeted: Bloodloss

Intervention: Trasylol (Aprotinin, BAYA0128) (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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

Official title: 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

Study design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: The primary criterion for efficacy is the 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 outcome:

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

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

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

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

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)

Blood loss during surgery, based on qualitative and quantitative estimates

The change from preoperative hemoglobin concentration to postoperative hemoglobin concentration (obtained in the morning of Day 3, or, if transfused earlier, prior to transfusion).

Surgeons assessment of the degree to which bleeding obscured his/her view of the surgical field, relative to past, similar procedures

The percent of patients receiving colloid or other blood products, and the number of units transfused

Changes in blood markers related to inflammation and blood coagulation

Changes in FEV1

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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. The Cockcroft-Gault formula to be used for the calculation of creatinine clearance is as follows:

[(140-age)x (weight in kg) x 1. 23 x (0. 85 only if female)]/ (serum creatinine in micromoles/L).

- 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.

Methods of contraception that are considered reliable are intrauterine devices (IUDs), birth control pills, hormonal implants/patches, and barrier contraception when used with spermicidal products. The "Rhythm" method is not considered 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).

Barcelona 08035, Spain

Barcelona 08036, Spain

Barcelona 08003, Spain

Madrid 28034, Spain

Valencia 46010, Spain

Karlsbad, Baden-Württemberg / 275 76307, Germany

Berlin, Berlin / 285 13353, Germany

Berlin, Berlin / 285 13086, Germany

Münster, Nordrhein-Westfalen / 298 48149, Germany

Oshawa, Ontario L1G 2B9, Canada

Windsor, Ontario N9A 1E1, Canada

Montreal, Quebec H3A 2B4, Canada

Neustadt, Schleswig-Holstein / 306 23730, Germany

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Starting date: February 2006
Ending date: March 2007
Last updated: April 25, 2008