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      Safety and Efficacy of Single Bolus Anticoagulation with Enoxaparin for Chronic Hemodialysis. Results of an Open-Label Post-Certification Study

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          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.

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          Comparison of low-molecular-weight heparin (enoxaparin sodium) and standard unfractionated heparin for haemodialysis anticoagulation.

          Low-molecular-weight heparin (LMWH) has been suggested as providing safe, efficient, convenient and possibly more cost-effective anticoagulation for haemodialysis (HD) than unfractionated heparin, with fewer side-effects and possible benefits on uraemic dyslipidaemia. In this prospective, randomized, cross-over study we compared the safety, clinical efficacy and cost effectiveness of Clexane (enoxaparin sodium; Rhône-Poulenc Rorer) with unfractionated heparin in 36 chronic HD patients. They were randomly assigned to either Clexane (1 mg/kg body weight, equivalent to 100 IU) or standard heparin, and followed prospectively for 12 weeks (36 dialyses) before crossing over to the alternate therapy for a further 12 weeks. Heparin anticoagulation was monitored using activated coagulation times. Dialysis with Clexane resulted in less frequent minor fibrin/clot formation in the dialyser and lines than with heparin (P<0.001), but was accompanied by increased frequency of minor haemorrhage between dialyses (P<0.001). Clexane dose reduction (to a mean of 0.69 mg/kg) eliminated excess minor haemorrhage without increasing clotting frequencies. Mean vascular compression times were similar in both groups. Over 24 weeks, no changes in standard serum lipid profiles were observed. This study suggests that a single-dose protocol of Clexane is an effective and very convenient alternative to sodium heparin, but currently direct costs are about 16% more. We recommend an initial dose of 0.70 mg/kg.
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            A single dose of dalteparin effectively prevents clotting during haemodialysis.

            A single bolus dose of LMW heparin at the start of haemodialysis effectively prevents clot formation in the dialyser and bubble trap. However, there are few studies on the appropriate dosage of LMW heparins in haemodialysis. Therefore we examined the relationship between the anticoagulant effect of dalteparin and clinical clotting during haemodialysis. We performed an open, prospective study on the effect of decreasing doses of dalteparin in 12 haemodialysis patients during a total of 84 sessions (4-4.5 h). The normally applied dose of dalteparin in each patient was reduced by 25% for each session down to 50% of initial dose if no clotting was observed. Clinical clotting (grade 1-4) was evaluated by visual inspection after blood draining of the air trap every hour and by inspection of the dialyser after each session and compared to corresponding values for anti-FXa activity and dialysis time. Blood flow and ultrafiltration rate were kept within narrow limits throughout the study. No episodes of grade 4 clotting occurred, and no session was interrupted. Eighteen episodes of grade 3 clinical clotting (11%) were observed in patients without warfarin treatment, none with an anti-FXa activity >0.43 IU/ml. Oral warfarin treatment reduced the clinical clotting, and only one grade 3 episode was observed in patients on warfarin therapy. Anti-FXa activity and haemodialysis time were the only factors independently correlated to clotting in a logistic regression model. An anti-FXa activity above 0.4 IU/ml after 4 h of dialysis inhibits significant clotting during haemodialysis. A bolus dose of dalteparin of 70 IU/kg usually seems appropriate, but may be reduced in patients on warfarin treatment. Dialysis time is an independent risk factor for clinical clotting.
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              Standard Heparin versus Low-Molecular-Weight Heparin

              Background: To compare standard heparin (SH) and low molecular weight heparin (LMWH) in terms of anticoagulation, platelet activation and lipid metabolism, we selected 54 patients who had been on 4-hour hemodialysis three times weekly for at least 12 months, without bleeding disorders or dyslipidemic diseases. 28 were on hemodialysis with Polysulfone low-flux, 26 were on hemodiafiltration with Polysulfone high-flux. All patients underwent EPO. Methods: During the first 18 months, we administered SH 1,500 IU on starting dialysis and 1,500 ± 500 IU in continuous intradialytic infusion per session. In the following 18 months, we administered LMWH 64.6 IU/kg on starting dialysis in a single arterious bolus. We assessed aPTT, anti-factor Xa activity, TAT and FPA, β-TG and PF4. Blood samples were taken monthly at times 0, 30, 60, 180 and 240 min, as well as 1, 4 and 20 h after dialysis end. Predialysis cholesterol, HDL, LDL, triglycerides and lipoprotein(a) were checked monthly. Results: During both LMWH and SH sessions no clotting or major bleeding complications were observed. APTT with LMWH was lower than that found with SH (p < 0.001); aFXa using LMWH was higher than when using SH (p < 0.001); TAT and FPA were lower in LMWH sessions (p < 0.01) than in SH sessions. We also detected lower β-TG (p < 0.05) and PF4 levels (p < 0.05) using LMWH than using SH. As regards lipids, we only observed a significant decrease in triglycerides after 18 months of LMWH treatment. Conclusions: Routine use of LMWH during hemodialysis affords a safe and effective alternative to SH, and causes reduced platelet activation.
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                Author and article information

                Journal
                KBR
                Kidney Blood Press Res
                10.1159/issn.1420-4096
                Kidney and Blood Pressure Research
                S. Karger AG
                1420-4096
                1423-0143
                2004
                September 2004
                08 September 2004
                : 27
                : 4
                : 211-217
                Affiliations
                aApheresis Research Institute, Cologne; bFirst Department of Internal Medicine, University of Mainz, Mainz; cInstitute for Laboratory Medicine, University of Mainz, Mainz; dInstitute for Statistics (SIMW), Wegberg, and eAventis, Bad Soden, Germany
                Article
                79866 Kidney Blood Press Res 2004;27:211–217
                10.1159/000079866
                15273423
                © 2004 S. Karger AG, Basel

                Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

                Page count
                Figures: 2, References: 22, Pages: 7
                Product
                Self URI (application/pdf): https://www.karger.com/Article/Pdf/79866
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