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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
54
Infusion of aprotinin (loading dose of 2 million KIU (Kallikrein Inhibitor Units) followed by 500,000 KIU/hour until the end of surgery)
Infusion of placebo (loading dose of 2 million KIU (Kallikrein Inhibitor Units) followed by 500,000 KIU/hour until the end of surgery)
Unnamed facility
Oshawa, Ontario, Canada
Unnamed facility
Windsor, Ontario, Canada
Unnamed facility
Montreal, Quebec, Canada
Unnamed facility
Karlsbad, Baden-Wurttemberg, Germany
Percent of patients requiring a blood transfusion (blood or packed red blood cells, autologous or allogenic)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: surgery to discharge
The number of units of blood or packed red cells transfused per patient requiring transfusion
Time frame: 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)
Time frame: surgery to discharge
Blood loss during surgery, based on qualitative and quantitative estimates
Time frame: surgery
The change from preoperative hemoglobin concentration to postoperative hemoglobin concentration (obtained in the morning of Day 3, or, if transfused earlier, prior to transfusion).
Time frame: pre-op and day 3 post surgery
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Unnamed facility
Münster, North Rhine-Westphalia, Germany
Unnamed facility
Neustadt, Schleswig-Holstein, Germany
Unnamed facility
Berlin, Germany
Unnamed facility
Berlin, Germany
Unnamed facility
Barcelona, Spain
Unnamed facility
Barcelona, Spain
...and 4 more locations
Surgeons assessment of the degree to which bleeding obscured his/her view of the surgical field, relative to past, similar procedures
Time frame: surgery to discharge
The percent of patients receiving colloid or other blood products, and the number of units transfused
Time frame: surgery to discharge
Changes in blood markers related to inflammation and blood coagulation
Time frame: surgery to discharge
Changes in FEV1
Time frame: surgery to discharge