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CSL Behring Announces First Patient Treated in Phase III Study of Fibrinogen Concentrate (Human)(FCH) to Control Bleeding During Aortic Aneurysm Surgery
Date:3/15/2012

ors for bleeding disorders, we are pleased that this important Phase III study of FCH in aortic aneurysm surgery is underway," said Russell Basser, M.D., Senior Vice President, Global Clinical R&D. "CSL Behring is committed to exploring the use of FCH in patients at high risk of bleeding resulting from cardiac surgery and providing optimal, uncompromised therapy to cardiac surgery teams and patients." 

About the REPLACE Study

REPLACE (Randomized evaluation of fibrinogen versus placebo in complex cardiovascular surgery) is a Phase III, prospective, multinational, multicenter, randomized, double-blind, placebo-controlled, two-arm study. Patients undergoing elective thoracic aortic surgery are randomized 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, standardized 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. For more information visit www.clinicaltrials.gov and search with identifier: NCT01475669.

About Fibrinogen and Fibrinogen Concentrate

Fibrinogen, also called Factor I, is a protein needed to form blood clots and, thereby, to stop bleeding. Fibrinogen levels in plasma determine the potential clotting ability and activity in the body. Diminished concentrations of fibrinogen limit the body's ability to form a clot and increase the risk of uncontrolled bleeding. A simple blood test can detect the level of fibrinogen; the normal range is 2-4 grams per liter. In patients undergoing cardiopul
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