"Fibrinogen concentrate has been well-characterized for the treatment of specific inherited blood clotting disorders," said Andrew Cuthbertson, CSL Chief Scientist. "CSL Behring is committed to exploring the use of fibrinogen concentrate in patients at high risk of bleeding, particularly those in the hospital setting where fibrinogen has been shown to be depleted by surgical procedures and where a quick intervention is needed to improve clotting and prevent serious bleeding events."About the StudyThe Phase II prospective, randomized, double-blind, placebo-controlled, parallel-group, stratified clinical study was conducted at the Hannover Medical School, Hannover, Germany. The study enrolled patients 18 years or older who were undergoing elective aortic replacement surgery with cardiopulmonary bypass. Patients were excluded from the study if they had undergone previous surgery at the same aortic site, had a congenital or acquired coagulation disorder, had a myocardial infarction or stroke in the previous two months, or if they used aspirin, clopidogrel or vitamin K antagonists before the surgery.
Phase II Study Indicates That Fibrinogen Concentrate Given As A First-Line Therapy Safely Reduces Need For Transfusion After Aortic Surgery
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