Aprotinin in fibrin tissue adhesives induces specific antibody response and increases antibody response of high-dose intravenous application

Background: In cardiac operations, aprotinin therapy is used either locally as a component of commercially available fibrin tissue adhesives, intraven ously, or combined. Our aim was to examine the formation of aprotinin-speci fic antibodies with regard to the application mode. Methods: Sera of 150 pa tients who had undergone cardiac operations and were receiving aprotinin th erapy for the first time were sampled before the operation and at medians o f 3.5 and 13.3 months after the operation. Aprotinin-specific IgG including all subgroups and aprotinin-specific IgE were analyzed. Aprotinin was give n locally las contained in fibrin sealant; n = 45; median dose, 6000 KIU), intravenously (n = 46; 2.000 x 10(6) KIU), and combined (n = 59; 2.012 x 10 (6) KIU). Results: At 3.5 months, the prevalence of aprotinin-specific IgG antibodies was 33% (15/45 patients) after local, 28% (13/46 patients) after intravenous, and 69% (41/59 patients) after combined exposure (P = .0001). At 13.3 months, the prevalence of aprotinin-specific IgG antibodies was 10 % (4/41 patients) after local, 31% (13/42 patients) after intravenous, and 49% (28/57 patients) after combined exposure. Total aprotinin dose was simi lar in patients who were antibody positive and negative. Before the operati on, no aprotinin-specific antibodies were detected. Aprotinin-specific IgE were not found after the operation. Conclusion: Local aprotinin contact ind uces a specific immune response and reinforces that of intravenous exposure . The antibody spectrum is identical to the immune response induced by intr avenous exposure. Any exposure should be documented. For use in cardiac ope rations as a hemostyptic, the necessity itself and alternatives for aprotin in as a stabilizing agent merit consideration.