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      Comparison of Two Dialysers (AN69ST vs. FX100) for Heparin-Free Dialysis in Patients with Oral Anticoagulation

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          Abstract

          Background: Heparin-free dialysis (HFD), i.e. only priming of the dialyser and no systemic heparinization, might reduce the risk of bleeding in dialysis patients receiving oral anticoagulation. The efficacy of HFD with two different membranes [polyacrylonitrile (AN69ST) vs. polysulphone (FX100)] was therefore investigated. Methods: In a crossover design, 10 patients were treated with either membrane for 1 week (total 30 sessions). Weekly Kt/V and urea reduction rate (URR) were measured and thrombus formation evaluated by measurement of D-dimer and inspection of the air traps and dialyser. Results: Change of clotting markers was similar with both membranes. Complete thrombosis occurred in 3/30 patients with the AN69ST and in 1/30 patients with the FX100 membrane. Kt/V did not differ between the groups, but the URR was slightly higher with the FX100. Conclusion: HFD prevents dialyser occlusion in the majority of patients treated with oral anticoagulants. Both polysulphone and polyacrylonitrile membranes seem to be equally effective.

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          Most cited references 11

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          The outpatient bleeding risk index: validation of a tool for predicting bleeding rates in patients treated for deep venous thrombosis and pulmonary embolism.

          Long-term anticoagulation prevents recurrent thrombosis in patients with idiopathic deep venous thrombosis or pulmonary embolism, but with a risk of clinically important so-called major bleeding. Physician- and patient-based decisions on the optimal duration of therapy are sensitive to the bleeding risk. The Outpatient Bleeding Risk Index potentially provides a means of calculating the potential risk of bleeding using easily elicited clinical findings, but, to our knowledge, the authors of the index have provided the only published validation of it. We sought to determine the accuracy of the index in our population of patients. We prospectively applied the Outpatient Bleeding Risk Index to consecutive patients in our clinic who had been objectively diagnosed as having pulmonary embolism or deep venous thrombosis and who were about to undergo standard therapy. Standard therapy consisted of a minimum of 5 days of low-molecular-weight heparin therapy overlapped with warfarin sodium therapy, and continuation of warfarin therapy for at least 3 months, with a target international normalized ratio of 2.5. Patients were placed in 3 risk groups (low, moderate, or high), as defined by the index. The survival curves of the groups, using major hemorrhages as the events, were then compared by the log-rank test. Bleeding rates were lower than expected, but the index did discriminate between low- and moderate-risk groups (P =.03, log-rank test). The rate of major hemorrhage per 100 person-years was 0% (95% confidence interval, 0%-2.8%) in the low-risk group and 4.3% (95% confidence interval, 1.1%-11.1%) in the moderate-risk group. The rate in the high-risk group could not be defined because only 2 patients were at high risk. The Outpatient Bleeding Risk Index discriminates between low- and moderate-risk patients, and could be used to guide decisions on the optimal duration of anticoagulant therapy.
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            Heparin-coated polyacrylonitrile membrane versus regional citrate anticoagulation: a prospective randomized study of 2 anticoagulation strategies in patients at risk of bleeding.

            Hemodialysis requires anticoagulation to prevent clotting of the extracorporeal circuit. Systemic anticoagulation with heparin is contraindicated in patients at high risk of bleeding. In these patients, regional citrate anticoagulation (RCA), with either calcium-free (RCA-Ca0) or calcium-containing dialysate (RCA-Ca3.0), and heparin-coated membranes (1.3 m(2); AN69ST; Nephral 300ST, Gambro-Hospal, Meyzieu, France) may represent valid alternatives. To compare the efficacy and safety of these regional anticoagulation modalities, we performed a prospective randomized trial including 33 hemodialysis patients at high risk of bleeding. Regional anticoagulation was achieved by means of either AN69ST (11 patients, 31 sessions), RCA-Ca0 (11 patients, 32 sessions), or RCA-Ca3.0 (11 patients, 30 sessions). Patients assigned to RCA were dialyzed using a polysulfone membrane (1.3 m(2); F60; Fresenius Medical Care, Bad Homburg, Germany). Scheduled dialysis time was 4 hours. At the end of each dialysis session, the dialyzer was inspected for visible signs of thrombus formation and scored semiquantitatively (0, no clotting, to 4, severe clotting). Solute clearances were monitored at the second and fourth treatment hour as a parameter of subclinical clotting of the dialyzer. Clotting phenomena necessitating premature termination of the dialysis session were encountered in 39%, 13%, and 0% using AN69ST, RCA-Ca3.0, and RCA-Ca0, respectively (P < 0.005). All clotting with AN69ST occurred after the second treatment hour. Mean dialyzer clotting scores were 2.7, 1.5, and 1.1, respectively (P < 0.0001). Significantly greater instantaneous urea nitrogen clearances were achieved at 2 hours during RCA compared with AN69ST. Except for clotting phenomena, no adverse events were observed. Citrate provides superior regional anticoagulation compared with AN69ST membranes.
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              Optimal anticoagulation strategy in haemodialysis with heparin-coated polyacrylonitrile membrane.

              Binding of polycationic unfractionated heparin onto the modified AN69 polyacrylonitrile membrane, whose surface electronegativity has been neutralized by layering polyethyleneimine (AN69ST), produces stable coating. We investigated whether the heparin-coated membrane was suitable for regular haemodialysis with low heparin doses. Sheep were instrumented for extracorporeal circulation perfusing a dialyser equipped with either the AN69ST or the original AN69 membrane. Dialysis sessions were performed after priming the dialyser with heparinized saline. The session was conducted without systemic administration of heparin. In chronic haemodialysis patients, the AN69ST membrane was tested for safety, clotting and thrombin generation according to protocols of 4-h haemodialysis sessions with tapered heparin doses. The goal was to define optimal heparin requirements with the heparin-coated membrane in the setting of continuous or intermittent administration of heparin. Both unfractionated and low molecular weight heparin (LMWH) (enoxaparin) were tested. In sheep, systemic heparin-free haemodialysis was conducted for 6 h without clotting using the heparin-coated dialyser. In the same conditions, massive clotting was observed within 90 min of dialysis with the native AN69 membrane. In man, through kinetic measurements of activated partial thromboplastin time (APTT), heparin anti-Xa concentration and thrombin-anti-thrombin complexes levels (TAT), significant dialyser clotting was avoided when APTT and anti-Xa concentration at 180 min of dialysis, were maintained at >40 s and >0.2 IU/ml, respectively. With the AN69ST heparin-coated membrane, thrombin generation was reduced then suppressed, as compared with the original AN69, primed in the same conditions. Safety of haemodialysis conducted with the AN69ST heparin-coated membrane and low doses of unfractionated heparin (50% reduction of the reference dose) was validated by a survey of 2590 sessions in 32 patients. Doses of LMWH were also safely reduced by 50%. In addition, haemodialysis without systemic administration of heparin was possible with minor risk of clotting. During the rinsing phase, the ionic interactions between the new AN69ST polyacrylonitrile membrane and unfractionated heparin induce stable heparin coating. This allows a significant reduction of systemic anticoagulant requirements without increasing the risk of clotting, both in the experimental setting and in the chronic haemodialysis patients. Further studies are required to assess this advantage in patients with acute renal failure and at risk of bleeding and to reduce the metabolic consequences of long-term treatment with heparin.
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                Author and article information

                Journal
                BPU
                Blood Purif
                10.1159/issn.0253-5068
                Blood Purification
                S. Karger AG
                0253-5068
                1421-9735
                2008
                May 2008
                28 February 2008
                : 26
                : 3
                : 226-230
                Affiliations
                aDepartment of Internal Medicine III, Division of Nephrology and Dialysis, bDepartment of Medical Statistics, University Hospital, and cDepartment of Nephrology and Dialysis, Wilhelminenspital, Vienna, Austria
                Article
                118846 Blood Purif 2008;26:226–230
                10.1159/000118846
                18305385
                © 2008 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
                Tables: 3, References: 15, Pages: 5
                Categories
                Original Paper

                Cardiovascular Medicine, Nephrology

                Thrombosis, Heparin, Oral anticoagulation, Haemodialysis, Dialyser

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