"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.
Before surgery, patients were randomized to receive either fibrinogen concentrate or placebo. Study medication was administered if clinically relevant bleeding occurred. Each 50 mL syringe contained either 1 g fibrinogen concentrate (Haemocomplettan ® P, RiaSTAP ® , CSL Behring, Marburg, Germany) diluted in 50 mL sterile water, or an equivalent volume of 0.9 percent saline as placebo. Doses were determined from the MCF value of the FIBTEM test, using a model developed in previous studies for individualizing fibrinogen concentrate dosing. ,  The FIBTEM test was performed by point-of-care thromboelastometry (ROTEM ® device, TEM International, Munich, Germany), using blood samples taken 20 min before the end of cardiopulmonary bypass. The time taken to obtain the MCF value was 15 min. The medications were administered intravenously within five minutes after bleeding measurement.
The primary endpoint was the total number of units of allogeneic blood components (red blood cells plus fresh frozen plasma plus platelet concentrate) given to patients between administration of study medication and 24 hours thereafter. Safety was evaluated by treatment-emergent adverse events occurring within 10 days of treatment, with follow-up for serious adverse events extended to 45 days.