title: Relative purity of thrombin-based hemostatic agents used in surgery.
abstract: BACKGROUND
  Hemostatic agents used in surgery contain thrombin isolated from either a bovine or human source. The use of thrombin derived from a bovine source has been associated with the development of an abnormal immune response, but a study of the immunoreactivity of the various commercially available thrombin preparations has not been conducted. This study determined the relative purity of commercially available thrombin preparations, if humans have natural antibodies that recognize these preparations, and if elicited antibodies against bovine thrombin cross-react with other bovine or human hemostatic agents.
  
  
  METHODS
  The purity of hemostatic agents was determined by protein and substrate assays, electrophoresis, and immunoblotting. The natural antigenicity and cross-reactivity of elicited antibodies were measured by ELISA using serum samples from 82 donors from the Red Cross and serum collected from patients exposed to bovine thrombin, respectively.
  
  
  RESULTS
  All of the bovine thrombin preparations were found to contain the xenogeneic carbohydrate galactosealpha1-3galactose. The natural antigenicity of the bovine thrombin preparations was greater than that of a human thrombin preparation and similar to that of porcine aortic endothelial cells. Antibodies elicited against bovine thrombin were found to cross-react with other bovine preparations and other xenoantigens but not with human hemostatic preparations.
  
  
  CONCLUSIONS
  All patients have antibovine thrombin antibodies, even before exposure to bovine thrombin-containing hemostatic agents. The cross-reactivity of elicited antibovine thrombin antibodies indicates that if a patient has been sensitized to a bovine product, it is likely safer to use a human-derived product in lieu of a bovine product.
authors.affiliation: Department of Pathology, Duke University Medical Center, Durham, NC, USA.
authors.forename: Jonathan G
authors.initials: JG
authors.lastname: Schoenecker
authors.forename: Rachel K
authors.initials: RK
authors.lastname: Johnson
authors.forename: Ryan C
authors.initials: RC
authors.lastname: Fields
authors.forename: Aaron P
authors.initials: AP
authors.lastname: Lesher
authors.forename: Taymon
authors.initials: T
authors.lastname: Domzalski
authors.forename: Kamran
authors.initials: K
authors.lastname: Baig
authors.forename: Jeffrey H
authors.initials: JH
authors.lastname: Lawson
authors.forename: William
authors.initials: W
authors.lastname: Parker
mesh_terms: D004187:Disaccharides / Q000032:analysis; D004340:Drug Contamination; D004797:Enzyme-Linked Immunosorbent Assay; D000939:Epitopes / Q000032:analysis; D015718:Fibrin Tissue Adhesive / Q000302:isolation & purification / Q000627:therapeutic use; D006488:Hemostasis, Surgical; D006490:Hemostatics / Q000302:isolation & purification; D013917:Thrombin / Q000302:isolation & purification / Q000627:therapeutic use*
chemical_list: D004187:Disaccharides; D000939:Epitopes; D015718:Fibrin Tissue Adhesive; D006490:Hemostatics; C055075:galactosyl-(1-3)galactose; D013917:Thrombin; C478632:Thrombogen