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Risk and clinical significance of developing antibodies induced by topical thrombin preparations
R P Dorion1, H F Hamati, B Landis
1Department of Laboratory Medicine and the Henry Hood, MD, Research Program, Geisinger Medical Center, Danville, PA 17822, USA.
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.