title: Risk and clinical significance of developing antibodies induced by topical thrombin preparations.
abstract: OBJECTIVE
  TO determine the clinical relevance, prevalence, and risk of antibody development in patients exposed to topical bovine thrombin preparations.
  
  
  METHODS
  A prevalence study of individuals previously exposed to topical bovine thrombin was done by screening using Western blot assay to detect antibodies against bovine thrombin preparations.
  
  
  METHODS
  A large tertiary care center.
  
  
  METHODS
  A convenience sample of 120 stored blood specimens from patients previously exposed to topical bovine thrombin was identified from hospital records. A control sample of 114 stored blood specimens from nonexposed patients was used. Case reviews for 2 exposed patients with severe bleeding complications and difficult clinical management are presented.
  
  
  RESULTS
  Twelve of the bovine thrombin-exposed patients were found to have antibodies directed against bovine thrombin and other coagulation factors (95% CI, 4.6%-15.4%). Patients receiving multiple exposures were 8 times more likely to develop antibodies than were patients with a single exposure (P < .001).
  
  
  CONCLUSIONS
  (1) Topical bovine thrombin is associated with formation of antibodies to coagulation factors; (2) Patients receiving multiple exposures are more likely to develop antibodies to coagulation factors; and (3) Topical bovine thrombin use may cause severe bleeding problems and should be avoided if there has been previous exposure.
authors.affiliation: Department of Laboratory Medicine and the Henry Hood, MD, Research Program, Geisinger Medical Center, Danville, PA 17822, USA.
authors.forename: R P
authors.initials: RP
authors.lastname: Dorion
authors.forename: H F
authors.initials: HF
authors.lastname: Hamati
authors.forename: B
authors.initials: B
authors.lastname: Landis
authors.forename: C
authors.initials: C
authors.lastname: Frey
authors.forename: D
authors.initials: D
authors.lastname: Heydt
authors.forename: D
authors.initials: D
authors.lastname: Carey
mesh_terms: D000287:Administration, Topical; D000368:Aged; D000818:Animals; D000917:Antibody Formation; D000937:Antigen-Antibody Reactions; D001780:Blood Coagulation Tests; D015153:Blotting, Western; D002417:Cattle; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D019106:Postoperative Hemorrhage / Q000453:epidemiology* / Q000276:immunology; D015995:Prevalence; D012307:Risk Factors; D013917:Thrombin / Q000276:immunology*
chemical_list: D013917:Thrombin