CSL Behring has announced 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 randomised, double blinded, placebo-controlled, multicentre 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 (eg., 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.
“Given the limitations of current treatment options, new safe and effective therapies are important for protecting cardiovascular surgery patients from severe bleeding and transfusion-associated adverse events,” says Niels Rahe-Meyer, professor and head of the Department of Anesthesiology and Intensive Care, Franziskus Hospital, Bielefeld, Germany and coordinating investigator of the study. “We look forward to analysing our findings from the REPLACE phase III study to determine if FCH treatment can safely and effectively reduce the number of transfusions needed during cardiovascular surgery.”
Timely and effective haemostatic management is important in cardiovascular surgery because the use of allogeneic blood transfusion can worsen clinical outcomes. In particular, studies have shown that blood transfusion during, or after, adult cardiovascular surgery is associated with increased long-term mortality.
“At CSL Behring, we are committed to improving the lives of people with serious health conditions by continuously working to address unmet medical needs with novel therapies,” says Charmaine Gittleson, senior vice president of Clinical Research and Development, CSL Behring. “This is a significant milestone in the study of fibrinogen concentrate and it brings us one step closer to providing an important treatment option to operating teams and their patients who are experiencing a bleed.”