FLORENCE, Italy--(BUSINESS WIRE)--CSL Behring announced today that the last patient has been treated as part of the REPLACE (Randomized Evaluation of fibrinogen versus PLACEbo in complex cardiovascular surgery) Phase III clinical trial. REPLACE is the first randomized, double blinded, placebo-controlled, multicenter study in a large population of patients evaluating fibrinogen concentrate (Human) (FCH) in controlling bleeding during aortic aneurysm surgery.
The REPLACE study was designed to demonstrate the safety, efficacy and tolerability of fibrinogen concentrate in reducing intraoperative bleeding and the amount 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 primary efficacy endpoint measured the total number of units of allogeneic blood products transfused during the first 24 hours after administration of FCH or placebo.
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