CSL Behring has announced 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 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% are used in cardiovascular surgery. Studies have shown that blood transfusion during or after adult cardiac surgery is associated with increased long-term mortality.
About the REPLACE study
REPLACE (Randomized evaluation of fibrinogen versus placebo in complex cardiovascular surgery) is a Phase III, prospective, multinational, multicentre, randomised, double-blind, placebo-controlled, two-arm study. Patients undergoing elective thoracic aortic surgery are randomised in a 1:1 ratio to treatment with FCH or placebo. Patients will receive a single intra-operative infusion if their blood loss amounts to 60 to 250g in 5 minutes after initial surgery is completed. Following infusion, a second 5-minute bleeding mass measurement is undertaken. If blood loss then still amounts to 60 g or more, the patient will be treated according to a predefined, standardised treatment regimen using allogeneic blood products. Reduction of allogenic blood products and other efficacy endpoints in addition to safety endpoints will be measured according to the trial protocol.