Bayer begins phase 3 study of Trasylol to reduce bleeding during spinal fusion surgery

By E. Janene Geiss

Philadelphia, Dec. 8 - Bayer Pharmaceuticals Corp. said Thursday that it has begun a phase 3 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.

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 to seven vertebral levels, according to a company news release.

Over 450 adult patients will be randomly assigned to receive 200 mL of intravenous Trasylol or placebo at the start of the operation, followed by 50 mL/hour of either agent until the surgery is complete. An initial IV test dose also will be administered.

Close to 40 investigational centers in North America will participate in the study, officials said.

Trasylol is 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 in the course of coronary artery bypass graft surgery, officials said.

Spinal fusion surgery involves "fusing" together one or more of the small bones of the spine with bone grafts and devices. About 300,000 of these surgeries take place each year in the United States, a figure that has doubled in the last decade, officials said.

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, officials said.

"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, lead investigator of the study and director of the Spine Institute at Beth Israel Medical Center, in the release.

Other recent Bayer studies evaluating aprotinin therapy in spine surgery demonstrated a significant reduction in blood loss and the amount of blood transfused, officials said.

Bayer Pharmaceuticals Corp., based in West Haven, Conn., is part of the worldwide operations of Bayer HealthCare AG, a subsidiary of Bayer AG.

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