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 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...

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Bibliographic Details
Published in:	Journal of biomedical materials research Vol. 58; no. 6; pp. 710 - 719
Main Authors:	Nelson, Patricia A., Powers, J. Noël, Estridge, Trudy D., Elder, Elizabeth A., Alea, Arcie D., Sidhu, Parmjeet K., Sehl, Louis C., DeLustro, Frank A.
Format:	Journal Article
Language:	English
Published:	New York John Wiley & Sons, Inc 2001 John Wiley & Sons
Subjects:	Animals anti-Factor V antibodies Antibodies, Heterophile - biosynthesis Antibodies, Heterophile - immunology anticollagen antithrombin Biological and medical sciences Blotting, Western Cattle - immunology Collagen - adverse effects Collagen - immunology Collagen - isolation & purification Collagen - therapeutic use Electrophoresis, Polyacrylamide Gel Enzyme-Linked Immunosorbent Assay Factor V - immunology Factor Va - immunology Hemostatics - adverse effects Hemostatics - immunology Hemostatics - therapeutic use Humans Immunization Medical sciences Safety Species Specificity Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases Technology. Biomaterials. Equipments Thrombin - adverse effects Thrombin - immunology Thrombin - isolation & purification Thrombin - therapeutic use Human Bovine Hemostatic General surgery Antibody Surgical hemostasis Cardiovascular disease Autologous system Antithrombin Blood plasma Factor V Vertebrata Mammalia Treatment Hemostasis Collagen Serological method Animal protein Artiodactyla ELISA assay Ungulata Bibliographic review
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Summary:	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
Bibliography:	ArticleID:JBM10025 The authors are employed by Cohesion Technologies, which is the sponsor of the FDA-approved human clinical trial and has a financial interest in the materials discussed in this article. istex:4380E11457797988CB5C2AE815B7944A768B4C31 ark:/67375/WNG-MLB4W7CW-C The authors are employed by Cohesion Technologies, which is the sponsor of the FDA‐approved human clinical trial and has a financial interest in the materials discussed in this article. ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-1 ObjectType-News-3 content type line 23
ISSN:	0021-9304 1097-4636
DOI:	10.1002/jbm.10025