TY - JOUR
T1 - Relative purity of thrombin-based hemostatic agents used in surgery
AU - Schoenecker, Jonathan G.
AU - Johnson, Rachel K.
AU - Fields, Ryan C.
AU - Lesher, Aaron P.
AU - Domzalski, Taymon
AU - Baig, Kamran
AU - Lawson, Jeffrey H.
AU - Parker, William
N1 - Funding Information:
This work was supported by the American Heart Association (JHL), the Department of Surgery at Duke University Medical Center, and the Fannie E Rippel Foundation. Dr Lawson is a Clinician Scientist Awardee from the American Heart Association and Genentech, Inc (95004380).
PY - 2003/10
Y1 - 2003/10
N2 - 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. STUDY DESIGN: 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 galactoseα1-3galactose. 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.
AB - 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. STUDY DESIGN: 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 galactoseα1-3galactose. 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.
UR - http://www.scopus.com/inward/record.url?scp=1242351602&partnerID=8YFLogxK
U2 - 10.1016/S1072-7515(03)00670-7
DO - 10.1016/S1072-7515(03)00670-7
M3 - Article
C2 - 14522327
AN - SCOPUS:1242351602
SN - 1072-7515
VL - 197
SP - 580
EP - 590
JO - Journal of the American College of Surgeons
JF - Journal of the American College of Surgeons
IS - 4
ER -