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Drug for reducing blood loss during THR enters phase 3 study

Previous studies of Trasylol (aprotinin injection) have noted adverse event rates comparable to placebo, including rates of deep vein thrombosis.

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Bayer Pharmaceuticals Corp. has initiated a phase 3 clinical trial evaluating Trasylol for reducing blood loss in patients undergoing primary total hip replacement, the company announced.

The FDA approved Trasylol (aprotinin injection, Bayer) in 1993 for prophylactic use in patients undergoing coronary artery bypass graft (CABG) surgery. The drug, which is available to surgeons in more than 60 countries worldwide, inhibits multiple mediators that lead to inflammatory responses. During CABG surgery, this results in reduced bleeding and decreased need for allogeneic blood transfusions, according to a press release from Bayer.

The new phase 3 double-blind, placebo-controlled study will evaluate the effects of Trasylol on blood loss, dryness of the surgical field and the need for transfusion in patients undergoing primary THR. Researchers plan to randomly assign 360 patients at 34 centers across North America to receive a single prophylactic intravenous injection containing either 200 mL of Trasylol or placebo at the start of surgery, followed by 50 mL injections each hour until the end of the operation.

"Since Trasylol is widely used as a hemostatic agent ... in CABG surgery, we are investigating its effects in primary THR where blood loss may result in unnecessary exposure to donor blood," David Nazarian, MD, a hip and knee surgeon at Pennsylvania Hospital in Philadelphia, said in the press release. "Current blood supply shortages and the rising cost of this precious commodity, along with potential health risks associated with transfusions, underscore the need for a therapeutic option in this setting," he added.

Previous studies have demonstrated a significant benefit from the drug in patients undergoing THR. Some studies have also noted rates of adverse events comparable to placebo, including the occurrence of deep vein thrombosis, the company noted.