Objectives

The three HAT trials examined whether lepirudin administered iv to patients with serologically confirmed HIT would safely reduce the risk of new arterial or venous thrombosis, limb amputations, and death (composite endpoint). The laboratory objective was to determine whether the drug would allow an increase in the platelet count in thrombocytopenic patients or maintain the baseline platelet values (in nonthrombocytopenic patients), while providing effective anticoagulation. The latter was defined as a prolongation of the aPTT by 1.5- to 2.5-fold over baseline values with no more than two dose increases. (Note: If Actin FS or Neothromtin reagents were used, the aPTT target range was a 1.5- to 3.0-fold prolongation.)

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