Serological analysis of patients treated with a new surgical hemostat containing bovine proteins and autologous plasma

A randomized, controlled clinical study of the management of diffuse bleedi ng with CoStasis (R) surgical hemostat, a new hemostat containing bovine th rombin and collagen with the patient's own plasma, included patients underg oing cardiac, hepatic, iliac, and general surgery. Sera from 92 patients tr eated with CoStasis and 84 control patients were collected preoperatively a nd at a post surgical follow-up of 8 weeks. Among the control group, 57 pat ients were treated with Instat (R) collagen sponge in noncardiac Indication s. Results showed that antibody responses in the CoStasis clinical study we re similar to the reported literature for all antigens screened and were no t associated with any adverse reactions. The bovine thrombin preparations i n CoStasis and other commercially available thrombins were compared with th e use of SDS-PAGE and Western blot analyses. Within this clinical study, Co Stasis was shown to be a safe and effective hemostatic product containing b ovine thrombin and bovine collagen and no pooled human blood products. (C) 2001 John Wiley & Sons, Inc.