CSL Behring initiates FCH Phase III trial to control bleeding during cardiovascular surgery

CSL Behring announced today that the first patient has been treated as part of the REPLACE Phase III clinical trial evaluating the efficacy and safety of fibrinogen concentrate (Human) (FCH) in controlling microvascular bleeding during aortic aneurysm surgery.

The purpose of this study is to demonstrate that Fibrinogen Concentrate (Human)(FCH) can reduce intraoperative bleeding and, therefore, the volume of donor blood products (e.g., fresh frozen plasma, platelets, and red blood cells) needed during complex cardiovascular surgical procedures such as aortic aneurysm surgery. The study will also aim to show that FCH is safe and well tolerated. The primary efficacy endpoint measurement will be the number of units of all allogeneic blood products transfused during the first 24 hours after administration of FCH or placebo. 

"Potentially life-threatening bleeding events can occur during cardiovascular surgery because the patient's fibrinogen levels are depleted, which delays clotting," said Dr. Niels Rahe-Meyer, Department of Anesthesiology and Intensive Care, Franziskus Hospital, Bielefeld, Germany and coordinating investigator  of the study. "The REPLACE Phase III study will help determine if FCH treatment can safely reduce the number of transfusions needed during cardiovascular surgery. If this is the case, we will have a powerful new option for use in protecting cardiovascular surgery patients from potentially life-threatening bleeding and transfusion-associated adverse events and discomfort." 

Of the 12 million units of blood used in the United States each year, 15 percent are used in cardiovascular surgery. Studies have shown that blood transfusion during or after adult cardiac surgery is associated with increased long-term mortality.

"As a global leader in the development of plasma-derived and recombinant coagulation factors for bleeding disorders, we are pleased that this important Phase III study of FCH in aortic aneurysm surgery is underway," said Russell Basser, M.D., Senior Vice President, Global Clinical R&D. "CSL Behring is committed to exploring the use of FCH in patients at high risk of bleeding resulting from cardiac surgery and providing optimal, uncompromised therapy to cardiac surgery teams and patients."