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Bayer launches Phase III clinical study of Trasylol in elective spinal fusion surgery

Bayer Pharmaceuticals Corporation (NYSE: BAY) today announced the initiation of a Phase III clinical trial to evaluate the safety and efficacy of Trasylol (aprotinin injection) in reducing blood loss and the need for transfusion in adult patients undergoing elective spinal fusion surgery.

Spinal fusion surgery involves 'fusing' together one or more of the small bones of the spine with bone grafts and devices. This fusion limits the motion between the vertebrae allowing surgeons to treat injuries to the spine, repair broken vertebra, correct deformities, adjust abnormal curvatures, stabilize weakness and remedy slipped or herniated disks. Approximately 300,000 spinal fusion surgeries take place each year in the United States, a figure that has doubled in the last decade (1).

Patients undergoing spinal fusion surgery are subject to a blood transfusion rate that may be six times greater than that of patients undergoing spinal surgery without fusion (2). Spine fusion surgery is also associated with more complications (such as infection, chronic pain and neural injuries) as it requires more extensive dissection and longer operative time (3).

"Blood loss can be a significant complication of spine surgery. Combined with the potential health risks associated with transfusions and the rising cost of blood products, there is a great need to reduce bleeding in this surgical setting," said Michael Neuwirth, MD, lead investigator of the study and director of the Spine Institute at Beth Israel Medical Center. "Trasylol has been proven safe and effective in reducing blood loss and transfusion requirements in coronary artery bypass surgery, and we are studying the drug to determine if it may play a similar role in spinal fusion surgery."

The multi-center, randomized, double-blind, placebo-controlled trial will assess the ability of Trasylol to reduce bleeding and the need for blood transfusions in elective spinal fusion surgery involving three
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8-Dec-2005


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