First Patient Treated in Phase III Study of RiaSTAP (CSL Behring) to Control Bleeding in Aortic Aneurysm Surgery

The first patient has been treated as part of the REPLACE Phase III clinical trial evaluating the efficacy and safety of RiaSTAP (fibrinogen concentrate (Human)), from CSL Behring, in controlling microvascular bleeding during Aortic Aneurysm Surgery. The purpose of this study is to demonstrate that 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. 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, it will offer a powerful new option for use in protecting cardiovascular surgery patients from potentially life-threatening bleeding and transfusion-associated adverse events and discomfort, according to Dr. Niels Rahe-Meyer, Department of Anesthesiology and Intensive Care, Franziskus Hospital, Bielefeld, Germany and coordinating investigator of the study.