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Prepublished online as a Blood First Edition Paper on October 17, 2002; DOI 10.1182/blood-2002-04-1055.

Submitted April 5, 2002
Accepted August 14, 2002
Anti-hirudin antibodies following low-dose subcutaneous treatment with desirudin for thrombosis prophylaxis after hip-replacement surgery: incidence and clinical relevance
Andreas Greinacher*, Petra Eichler, Dorothea Albrecht, Ulrike Strobel, Bernd Poetzsch, and Bengt I Eriksson
Institute for Immunology and Transfusion Medicine, Ernst-Moritz-Arndt-University Greifswald, Greifswald, Germany
Insitute for Experimental Haematology and Transfusion Medicine, University Bonn, Bonn, Germany
Department of Orthopedic Surgery, Goeteborg University Sahlgrenska University Hospital/OESTRA, Goeteborg, Sweden
* Corresponding author; email: greinach{at}mail.uni-greifswald.de.
Recombinant hirudin has been found to be immunogenic in patients treated with lepirudin following heparin-induced thrombocytopenia (HIT). We assessed the incidence of IgG-anti-hirudin antibodies by ELISA in 112 patients enrolled in a dose finding study with desirudin. Patients received desirudin subcutaneously following orthopedic hip surgery 10 mg b.i.d. (n=17), 15 mg b.i.d. (n=75), 20 mg b.i.d. (n=20). 11/112 patients (9.8%) developed anti-hirudin antibodies independently of the dose (17.6%, 8.0%, 10.0%, n.s.). The rate of immunization did not differ from that observed in HIT patients treated with lepirudin (p=0.113). Plasma concentrations of desirudin did not differ between anti-hirudin antibody positive and negative patients. Anti-hirudin antibodies had no impact on incidences of deep vein thrombosis and/or pulmonary embolism, allergic reactions, hemorrhage. However, the total number of immunized patients observed was low, and so infrequent, but severe, effects of anti-hirudin antibodies cannot be excluded.

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