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

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Abstract
A randomized, controlled clinical study of the management of diffuse bleeding with CoStasis® surgical hemostat, a new hemostat containing bovine thrombin and collagen with the patient's own plasma, included patients undergoing cardiac, hepatic, iliac, and general surgery. Sera from 92 patients treated with CoStasis and 84 control patients were collected preoperatively and at a post surgical follow‐up of 8 weeks. Among the control group, 57 patients were treated with Instat® collagen sponge in noncardiac indications. Results showed that antibody responses in the CoStasis clinical study were similar to the reported literature for all antigens screened and were not associated with any adverse reactions. The bovine thrombin preparations in CoStasis and other commercially available thrombins were compared with the use of SDS‐PAGE and Western blot analyses. Within this clinical study, CoStasis was shown to be a safe and effective hemostatic product containing bovine thrombin and bovine collagen and no pooled human blood products. © 2001 John Wiley & Sons, Inc. J Biomed Mater Res (Appl Biomater) 58: 710–719, 2001