WEST HAVEN, Conn., April 11 — Bayer Pharmaceuticals Corporation has announced the initiation of a Phase III controlled clinical study to evaluate the safety and efficacy of Trasylol® (aprotinin injection) in reducing blood loss and the need for transfusion in patients undergoing elective primary total hip replacement surgery.
Trasylol is currently approved for use in more than 60 countries. In the United States, Trasylol is indicated for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass (CPB) in the course of coronary artery bypass graft (CABG) surgery. The drug acts by inhibiting multiple mediators resulting in the attenuation of inflammatory responses, which in CABG surgery translates into reduced bleeding and a decreased need for allogeneic (blood donated from another individual) blood transfusions. The double-blind, placebo-controlled trial has been initiated to assess the drug’s hemostatic (blood sparing) effects in primary total hip replacement surgery. Patients undergoing primary total hip replacement surgery lose an average of three units of blood, which often must be replaced by a transfusion.
“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,” said Dr. David Nazarian, hip and knee replacement specialist at Pennsylvania Hospital in Philadelphia. “Since Trasylol is widely used as a hemostatic agent in reducing the need for transfusion in CABG surgery, we are investigating its effects in primary total hip replacement where blood loss may result in unnecessary exposure to donor blood.”
In the study, 360 patients will be randomly assigned to prophylactically receive 200 mL of intravenous Trasylol or placebo at the start of the operation, followed by 50 mL/hr of either until the surgery is complete. The study is designed to evaluate the effect of Trasylol on the need for transfusion, blood loss, dryness of the surgical field and markers of inflammation. Approximately 34 investigational centers in North America will participate in the study.
“We are encouraged by previous study findings on the blood sparing effects of Trasylol in this setting,” said Dr. Paul MacCarthy, Vice President of Medical Affairs at Bayer. “We are hopeful that this clinical trial will validate those findings in this specific patient population.”