【体外膜肺ECMO精品课件】 Heparin-Induced Thrombocytopenia.pptVIP

The following dosing guidelines are based on the product inserts. Argatroban An initial dose of 2 μg/kg/min administered as a continuous infusion is recommended; standard infusion rate is based on body weight. After initial dose, adjust as clinically indicated (not to exceed 10 μg/kg/min). Patients with hepatic impairment require a dose adjustment. Lepirudin A bolus of 0.4 mg/kg (body weight up to 110 kg) is given slowly intravenously (eg over 15 to 20 seconds). This is followed by 0.15 mg/kg (body weight up to 110 kg) as a continuous intravenous infusion for 2 to 10 days or longer if clinically needed. Individual renal function should be considered prior to administration; dose adjustment should be based on creatinine clearance values. Argatroban injection product information. Lepirudin product information. The two studies (ARG-911 and ARG-915) were comparable with regard to study design and dosing regimens, as well as study outline, conduct, and monitoring.16 When these studies were conducted, no active comparator was available, and a placebo-controlled design was considered ethically untenable. Thus, the clinical outcomes of Argatroban-treated patients were compared with those for historical controls. The historical control group was considered to be representative of HIT patients in terms of anticipated outcomes and were managed with the standard of care at the time (eg, heparin withdrawal, oral anticoagulants). In both studies (ARG-911 and ARG-915) Argatroban significantly improved (p 0.05) the primary endpoint, a composite of death, amputation, or new thrombosis.16 The incidence of the composite outcome in HIT patients either with or without thrombosis was 34.2% with Argatroban in study 1 (ARG-911), 33.7% with Argatroban in study 2 (ARG-915), versus 43% with historical controls. Among Argatroban-treated patients, there was a 21% reduction in the risk of death, amputation, and new thrombosis (components of the composite endpoint) and delayed onset o