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J Thorac Cardiovasc Surg 2000;119:1278-1283
© 2000 The American Association for Thoracic Surgery

CARDIOPULMONARY SUPPORT AND PHYSIOLOGY

A QUICK ASSAY FOR MONITORING RECOMBINANT HIRUDIN DURING CARDIOPULMONARY BYPASS IN PATIENTS WITH HEPARIN-INDUCED THROMBOCYTOPENIA TYPE II: ADAPTATION OF THE ECARIN CLOTTING TIME TO THE ACT II DEVICE

From the Department of Anesthesiology,^a Deutsches Herzzentrum Berlin; Department of Laboratory Medicine and Pathobiochemistry,^b Campus Rudolf Virchow, Charité, Berlin; Department of Cardiothoracic and Vascular Surgery,^c Deutsches Herzzentrum Berlin; and Department of Anesthesiology and Intensive Care Medicine,^d University of Homburg-Saar, Germany.

Address for reprints: Andreas Koster, MD, Deutsches Herzzentrum Berlin, Augustenburgerplatz 1, 13353 Berlin, Germany (E-mail: koster{at}dhzb.de ).

Background: Recombinant hirudin is increasingly advocated as a promising alternative anticoagulation for patients with heparin-induced thrombocytopenia type II during cardiopulmonary bypass. This requires monitoring of the ecarin clotting time. No commercial ecarin clotting time assay is available for clinical use. We adapted the ecarin clotting time to the easy-to-handle ACT II device.
Methods: Three different concentrations of the ecarin reagent (20, 10, 5 U/mL) were investigated as preliminary studies. Standard calibration curves were constructed for concentrations of recombinant hirudin ranging from 0 to 5 µg/mL. In vivo samples were collected from patients with heparin-induced thrombocytopenia type II who underwent cardiopulmonary bypass, and the values were compared with the values obtained by the chromogenic method. The final concentration for the assay of 5 IU/mL ecarin was further assessed in vitro for reproducibility and the influence of variations in hematocrit, platelet count, and procoagulants.
Results: All three concentrations of ecarin revealed linearity to 5 µg/mL concentrations of recombinant hirudin. The ecarin concentration of 5 U/mL revealed the best correlation (0.87) to the laboratory method, was reproducible over the whole recombinant hirudin range, and was not influenced by the variations in the in vitro setup.
Conclusions: The ACT II/ecarin clotting time with an ecarin concentration of 5 U/mL is a simple and reliable assay for monitoring recombinant hirudin during cardiopulmonary bypass. Use of this assay allows a wider use of recombinant hirudin in patients with heparin-induced thrombocytopenia type II during bypass and thereby may contribute to the safer management of these patients.

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