Effect of Aprotinin on Transfusion Requirements in Patients Undergoing Elective Spinal Fusion Surgery
Information source: Bayer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bloodloss
Intervention: Trasylol (Aprotinin, BAYA0128) (Drug); Placebo (Drug)
Phase: Phase 3
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).
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.
- 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
- 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
- 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
- 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
- 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
- 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).
Locations and Contacts
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