Safety and efficacy of single bolus anticoagulation with enoxaparin for chronic hemodialysis. Results of an open-label post-certification study.

Abstract

BACKGROUND:

Low-molecular-weight heparin (LMWH) is supposed to be advantageous compared to unfractionated heparin for chronic hemodialysis (HD) with respect to lipid and bone metabolism, polymorphonuclear cell stimulation, induction of antibody-mediated thrombocytopenia, and aldosterone suppression. Due to longer biological half-life, LMWH offers the possibility of single bolus administration.

METHODS:

To assess safety and efficacy of single bolus anticoagulation with enoxaparin for chronic HD, 781 stable HD patients from 79 German dialysis centers (mean age 62 years; 31% ESRD due to diabetes mellitus) were monitored by clinical and laboratory parameters for 32 weeks. Additionally, in a single dialysis center, 22 chronic HD patients were investigated by molecular markers of coagulation during chronic HD under conditions of single bolus or continuous anticoagulation regimens. Anti-Xa activity and the thrombin- antithrombin-III complex (TAT) were determined before the enoxaparin bolus, after 15 min, 2 h, and at the end of HD in venous and arterial blood lines.

RESULTS:

Chronic HD was performed in 24,117 HD treatments with enoxaparin at a median dose of 70.1 IU/kg (5,000 IU median total dose) for single bolus anticoagulation. In 83.0% of HD treatments, enoxaparin was given as single bolus. In 98.3% of patients no adverse event was reported. No drug-related severe adverse event occurred. Significant clotting problems were observed in only 0.3% of HD treatments with single bolus anticoagulation. As assessed in 257 HD treatments, essentially identical anti-Xa levels were detected at the end of HD with single bolus (50 IU/kg) or continuous (mean total dose 43 IU/kg) anticoagulation regimens. Bolus anticoagulation resulted in higher TAT generation at the end of HD. However, this was not associated with increased macroscopic clot formation.

CONCLUSION:

Single bolus anticoagulation with enoxaparin was safe and effective for chronic HD. For a duration of 4 h HD, a median dose of 70 IU/kg can be recommended for regular use, which is in accordance with the manufacturer's instructions for use of enoxaparin recommending a range of 50-100 IU/kg.

• Authors: Reinhard Klingel, Andreas Schwarting, Johannes Lotz, Martin Eckert, Volker Hohmann, Gerd Hafner
• Journal: Kidney & blood pressure research (Kidney Blood Press Res) Vol. 27 Issue 4 Pg. 211-7 ( 2004) ISSN: 1420-4096 [Print] Switzerland
• PMID: 15273423 (Publication Type: Clinical Trial, Journal Article, Multicenter Study)
• Copyright: Copyright 2004 S. Karger AG, Basel

Chemical References

• Anticoagulants
• Enoxaparin
• Lipids
• Factor Xa

Topics

• Adult
• Aged
• Aged, 80 and over
• Anticoagulants (administration & dosage, adverse effects)
• Enoxaparin (administration & dosage, adverse effects)
• Factor Xa (metabolism)
• Female
• Humans
• Kidney Failure, Chronic (blood, therapy)
• Lipids (blood)
• Male
• Middle Aged
• Renal Dialysis
• Thrombosis (prevention & control)