Date: 2014-09-16
Type of information: Completion of the trial
phase: 3
Announcement: treatment of the last patient
Company: CSL Behring (Australia)
Product: fibrinogen concentrate
Action
mechanism: Fibrinogen, also called Factor I, is a protein needed for blood clotting and for stopping bleeding. Diminished concentrations of fibrinogen limit the body\'s ability to support clotting at the wound area and increase the risk of bleeding. In patients who undergo major surgery, such as aortic surgery, fibrinogen concentration and subsequently clot strength, decrease during the operation. Correcting the levels of fibrinogen in these patients is critical in controlling bleeding.
Disease: elective aortic surgery
Therapeutic area: Cardiovascular diseases
Country:
Trial
details: REPLACE is a Phase III, prospective, multinational, multicenter, randomized, double-blind, placebo-controlled, two-arm study. Patients undergoing elective aortic surgery were randomized in a 1:1 ratio to treatment with FCH or placebo. Five minutes after surgical haemostasis was completed, patients received a single intra-operative infusion of fibrinogen concentrate or placebo if their blood loss amounted to between 60 and 250 g. If blood loss of 60 g or more continued ten minutes after the administration of study medication was completed, the patient was treated according to a predefined, standardized treatment regimen using allogeneic blood products. (NCT01475669)
Latest
news: * On September 16, 2014, CSL Behring 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 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.
The REPLACE study follows CSL Behring’s Phase II prospective study, performed by the company and collaborators at the Hannover Medical School, Germany. Results from the Phase II study suggest proactive, targeted treatment with fibrinogen concentrate may safely reduce the need for transfusions and restore clotting ability in patients undergoing aortic surgery.
