OBJECTIVE: TO determine the clinical relevance, prevalence, and risk of antibody development in patients exposed to topical bovine thrombin preparations. DESIGN: 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. SETTING: A large tertiary care center. PATIENTS: 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.
OBJECTIVE: TO determine the clinical relevance, prevalence, and risk of antibody development in patients exposed to topical bovinethrombin preparations. DESIGN: A prevalence study of individuals previously exposed to topical bovinethrombin was done by screening using Western blot assay to detect antibodies against bovinethrombin preparations. SETTING: A large tertiary care center. PATIENTS: A convenience sample of 120 stored blood specimens from patients previously exposed to topical bovinethrombin 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 bovinethrombin-exposed patients were found to have antibodies directed against bovinethrombin 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 bovinethrombin 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 bovinethrombin use may cause severe bleeding problems and should be avoided if there has been previous exposure.
Authors: J G Schoenecker; R K Johnson; A P Lesher; J D Day; S D Love; M R Hoffman; T L Ortel; W Parker; J H Lawson Journal: Am J Pathol Date: 2001-11 Impact factor: 4.307
Authors: Paul Ness; Michael Creer; George M Rodgers; Joseph J Naoum; Kenneth Renkens; Stacy A Voils; W Allan Alexander Journal: Patient Saf Surg Date: 2009-05-22