Phase II study of RiaSTAP (CSL Behring) shows the drug has benefits in Critical Care patients

Clinical study results show that RiaSTAP (fibrinogen concentrate [human]), from CSL Behring, can significantly reduce the need for blood transfusion when given in a Critical Care situation, as an intra-operative, targeted first-line hemostatic therapy in bleeding patients undergoing aortic replacement surgery. The Phase II prospective study, led by Niels Rahe-Meyer of the Clinic for Anesthesiology and Intensive Care Medicine, at the Hannover Medical School, Germany, enrolled 61 patients to assess the ability of fibrinogen concentrate to improve clotting and reduce the need for transfusion following elective aortic replacement surgery with cardiopulmonary bypass (CPB).

Patients who received fibrinogen concentrate required fewer allogeneic blood product transfusions than patients receiving placebo (a median of 2 units in the fibrinogen concentrate group compared with 13 units in the placebo (p<0.001)). in the fibrinogen concentrate group, 45 percent (13 out of 29 patients) avoided transfusion entirely, whereas all 32 placebo patients required transfusion (p><0.001). data have been published in the journal anesthesiology. see: "effects of fibrinogen concentrate as first-line therapy during major aortic replacement surgery: a randomized, placebo-controlled trial" rahe-meyer, niels et al. anesthesiology. 118(1):40-50, january 2013. doi: 10.1097 aln.0b013e3182715d4d>