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Abstract
IntroductionThe aim of this study was to collect data in France in patients with heparin-induced thrombocytopenia who required parenteral anticoagulation and for whom other non-heparin anticoagulant therapies were contraindicated including patients with renal failure, cross-reactivity to danaparoid or at high hemorrhagic risk.MethodsA total of 20 patients, of mean age 72 ± 10 years, were enrolled in this open-label, multicenter clinical study. Exploratory statistical data analysis was performed with descriptive interpretation of intra-individual comparisons using simple univariate statistics.ResultsThe diagnosis of HIT was confirmed in 16 subjects by an independent scientific committee. Fourteen patients (70 %) were in an intensive care unit during the course of the study. Patients were treated with argatroban for a mean duration of 8.5 ± 6.1 days. The mean starting dose of argatroban was 0.77 ± 0.45 μg/kg/min. Platelet recovery was rapid.aPTT and anti-IIa activity assays were used to monitor the dose of argatroban. The mean baseline aPTT value was 45.0 ± 9.8 sec and increased to 78.2 ± 35.8 sec two hours after initiating argatroban. At this time mean argatroban concentration was 0.34 ± 0.16 and 0.61 ± 0.28 μg/ml using ECT and TT measurements, respectively. New and/or extended thromboses were reported in 25 % of patients and major bleedings were documented in 15 %. Six patients died due to their underlying medical condition.ConclusionConsidering its hepatic elimination and its short half-life, argatroban can be considered as a safe therapeutic option in HIT patients at high hemorrhagic risk and with renal failure, particularly in an ICU setting.
Highlights
The aim of this study was to collect data in France in patients with heparin-induced thrombocytopenia who required parenteral anticoagulation and for whom other non-heparin anticoagulant therapies were contraindicated including patients with renal failure, cross-reactivity to danaparoid or at high hemorrhagic risk
The four patients for whom serological tests could not confirm the diagnosis of heparininduced thrombocytopenia (HIT) were still included in the study based upon the strong clinical suspicion of HIT raised by the local physicians
It is noteworthy that the present study showed that the two methods were not superimposable with higher values with modified a thrombin time (TT) compared with the ecarin clotting time (ECT)
Summary
The aim of this study was to collect data in France in patients with heparin-induced thrombocytopenia who required parenteral anticoagulation and for whom other non-heparin anticoagulant therapies were contraindicated including patients with renal failure, cross-reactivity to danaparoid or at high hemorrhagic risk. For HIT patients an alternative parenteral anticoagulant is always needed for the prevention of the thrombotic risk associated with HIT and for the treatment of thrombosis related to HIT, or for continued anticoagulation. In France the current authorized treatment options for Argatroban is a synthetic thrombin inhibitor that offers potential benefit to patients with HIT. Argatroban is unique among direct thrombin inhibitors (and other anticoagulants) because it is predominantly hepatically metabolized, acts rapidly and has a short elimination half-life of 52 ± 16 minutes, ensuring rapid restoration of hemostasis upon cessation of treatment [4], which is of particular interest in elderly patients like those in our. Argatroban does not cross-react with heparindependent antibodies and does not induce antibody formation [5]
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