OBJECTIVE: To determine prospectively the immunologic response and adverse clinical events in surgical patients exposed to bovine thrombin during cardiac surgical procedures. SUMMARY BACKGROUND DATA: Topical bovine thrombin is used extensively as a hemostatic agent during cardiovascular surgery. Antibodies developing after exposure to bovine thrombin have been anecdotally associated with hemorrhagic complications. METHODS: One hundred fifty-one patients undergoing cardiac surgical procedures were prospectively recruited for this study before surgical exposure with topical bovine thrombin. Immunoassays were used to determine antibody levels against both bovine and human coagulation proteins before and after exposure to bovine thrombin. Alterations in coagulation assay parameters and adverse clinical events were followed in all patients enrolled in the study. RESULTS: Baseline elevated antibody levels to one or more bovine coagulation proteins were observed most frequently in patients with a prior history of a surgical procedure during which bovine thrombin is frequently used. More than 95% of patients developed a seropositive response to bovine coagulation proteins, and 51% manifested elevated antibody levels to the corresponding human coagulation proteins after bovine thrombin exposure. Postoperative coagulation abnormalities were more common in patients with antibodies to human coagulation proteins. Patients with multiple elevated antibody levels to bovine proteins before surgery were more likely to sustain an adverse clinical outcome after surgery. Using a logistic regression model, the adjusted odds ratio for sustaining an adverse event with multiple elevated antibody levels to bovine proteins before surgery was 5.40. CONCLUSIONS: Bovine thrombin preparations are highly immunogenic and appear to be associated with an increased risk for adverse clinical outcomes during subsequent surgical procedures. The clinical safety of these commonly used preparations needs to be reassessed, and reexposure to these agents should likely be avoided.
OBJECTIVE: To determine prospectively the immunologic response and adverse clinical events in surgical patients exposed to bovinethrombin during cardiac surgical procedures. SUMMARY BACKGROUND DATA: Topical bovinethrombin is used extensively as a hemostatic agent during cardiovascular surgery. Antibodies developing after exposure to bovinethrombin have been anecdotally associated with hemorrhagic complications. METHODS: One hundred fifty-one patients undergoing cardiac surgical procedures were prospectively recruited for this study before surgical exposure with topical bovinethrombin. Immunoassays were used to determine antibody levels against both bovine and humancoagulation proteins before and after exposure to bovinethrombin. Alterations in coagulation assay parameters and adverse clinical events were followed in all patients enrolled in the study. RESULTS: Baseline elevated antibody levels to one or more bovinecoagulation proteins were observed most frequently in patients with a prior history of a surgical procedure during which bovinethrombin is frequently used. More than 95% of patients developed a seropositive response to bovinecoagulation proteins, and 51% manifested elevated antibody levels to the corresponding humancoagulation proteins after bovinethrombin exposure. Postoperative coagulation abnormalities were more common in patients with antibodies to humancoagulation proteins. Patients with multiple elevated antibody levels to bovine proteins before surgery were more likely to sustain an adverse clinical outcome after surgery. Using a logistic regression model, the adjusted odds ratio for sustaining an adverse event with multiple elevated antibody levels to bovine proteins before surgery was 5.40. CONCLUSIONS:Bovinethrombin preparations are highly immunogenic and appear to be associated with an increased risk for adverse clinical outcomes during subsequent surgical procedures. The clinical safety of these commonly used preparations needs to be reassessed, and reexposure to these agents should likely be avoided.
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