Original ArticlesRecombinant hirudin as an alternative for anticoagulation during cardiopulmonary bypass in patients with heparin-induced thrombocytopenia type II: A 1-year experience in 57 patients*
Section snippets
Methods
The present study comprised a series of patients admitted for surgery between June 1997 (r-hirudin was approved by European regulatory authorities in May 17, 1997) and July 1998 (U.S. Food and Drug Administration approval). Within this period, 6,733 cardiac surgeries were performed. Of these, 57 patients (0.8%) requiring CPB were anticoagulated with r-hirudin instead of heparin.
Evidence of heparin-induced thrombocytopenia type II and cross-reactivity to orgaran
Of the 57 patients, 44 had a history of single or recurrent thromboembolic complications when previously hospitalized, and 16 patients had been diagnosed for HIT II (ie, HIPAA, PF 4 ELISA, clinical signs) (Table 1). Thirty-two patients were admitted with a platelet count less than 100 × 103/μL, and 10 patients developed a marked (>30%) decrease in platelet count during the administration of heparin (from 221 ± 72 × 103/μL to 43 ± 12 × 103/μL) (Table 1). In 46 patients, the HIPAA yielded a
Discussion
The development of a recombinant preparation for hirudin, r-hirudin, has facilitated the introduction of this anticoagulant into clinical practice. This agent is advantageous for use in patients with HIT II, because it is unreactive with HIT II—related antibodies and can be reliably monitored using the ECT.7, 12, 13, 14, 15, 17 The present study shows in a relatively large group of patients that r-hirudin is safe and effective for high-dose systemic anticoagulation during CPB in patients with
Acknowledgements
The authors are grateful to Mrs. Tony Derwent, for reviewing and editing the manuscript.
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Address reprint requests to Fritz Mertzlufft, MD, PhD, Klinik fuer Anaesthesiologie und Intensivmedizin, Universitaetskliniken des Saarlandes, D-66421 Homburg/Saar, Germany.