Argatroban in the management of heparin-induced thrombocytopenia: a multicenter clinical trial.

Abstract

INTRODUCTION:

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.

METHODS:

A 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.

RESULTS:

The 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.

CONCLUSION:

Considering 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.

• Authors: Brigitte Tardy-Poncet, Philippe Nguyen, Jean-Claude Thiranos, Pierre-Emmanuel Morange, Christine Biron-Andréani, Yves Gruel, Jérome Morel, Alain Wynckel, Lelia Grunebaum, Judith Villacorta-Torres, Sandrine Grosjean, Emmanuel de Maistre
• Journal: Critical care (London, England) (Crit Care) Vol. 19 Pg. 396 (Nov 11 2015) ISSN: 1466-609X [Electronic] England
• PMID: 26556106 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Anticoagulants
• Pipecolic Acids
• Sulfonamides
• Heparin
• Arginine
• argatroban

Topics

• Adult
• Aged
• Aged, 80 and over
• Anticoagulants (therapeutic use)
• Arginine (analogs & derivatives)
• Female
• Heparin (adverse effects)
• Humans
• Male
• Middle Aged
• Partial Thromboplastin Time
• Pipecolic Acids (therapeutic use)
• Platelet Count
• Sulfonamides
• Thrombocytopenia (chemically induced, drug therapy)
• Treatment Outcome