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      Comparison between Tinzaparin and Standard Heparin for Chronic Hemodialysis in a Canadian Center

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          Abstract

          Background: Low-molecular-weight heparins offer several advantages over standard heparins, but their use for maintenance hemodialysis has been limited in North America because of their higher cost. Our objective was to compare tinzaparin to standard heparin during maintenance hemodialysis over an 8-week period, in regard to the visual aspect of the extracorporeal circuit, filter reuse, bleeding and time for compression of vascular access at the end of hemodialysis session, nursing time devoted to anticoagulation administration, level of satisfaction of patients and nurses, and relative cost. Methods: Thirty-two chronic hemodialysis adult patients with peripheral accesses were randomly divided into two groups in a cross-over design: tinzaparin for 4 weeks followed by standard heparin for 4 weeks, or vice versa. Hemodialysis was performed thrice weekly over 3.5–4 h using large surface reused filters. Standard heparin was administered as an initial bolus of 50–75 units per kilogram followed by an infusion to maintain an activated clotting time (ACTESTER) between 150 and 200 s and discontinued 30–45 min before the end of the session. The initial dose of tinzaparin was 3,500 IU anti-Xa for patients usually receiving 7,500 units or less of standard heparin, or 4,500 IU anti-Xa for patients receiving more than 7,500 units of standard heparin, and it was injected as a bolus in the arterial line at the beginning of hemodialysis. Dosage adjustments were made by increments or decrements of 500 IU. Results: A total of 6 patients did not require any adjustment in their dose of tinzaparin and remained at the initial dose, while the remaining 26 necessitated adjustments of the initial dose of tinzaparin: 20 patients required increments from the initial dose whereas 6 required reductions. For most patients, 27 of them, the standard heparin dose was kept at the same level throughout the study period (since it was their usual regimen and they were in stable medical conditions). According to the monitoring scale, the visual aspects of the tubing of the extracorporeal circuit and of the dialyzers at the end of the session were similar for both tinzaparin and standard heparin. The time of compression of the vascular access at the end of the hemodialysis sessions was not significantly different with tinzaparin than with standard heparin. However, as indicated below, most patients noted less bleeding (or oozing) from their access (during compression and thereafter, in the few hours after hemodialysis) with tinzaparin than with standard heparin. Clotting was observed more frequently in the arterial and venous bubble traps with tinzaparin than with standard heparin. The presence of clot(s) was observed in the arterial and venous bubble traps in, respectively, 18 ± 12 and 10 ± 6% of the sessions with tinzaparin, while in, respectively, 3 ± 4 and 2 ± 4% of the sessions with standard heparin (p < 0.005). Despite a tendency for a reduced reuse number of the dialyzers, the difference did not reach statistical significance. Among the 30 patients who completed the study, 2 reported excessive bleeding from their vascular access with tinzaparin whereas 8 reported such an excessive bleeding with standard heparin. The level of satisfaction of patients and nurses for tinzaparin was extremely good. The main reasons stated by the patients was reduced bleeding from their access after dialysis. The nurses preferred tinzaparin because of the simplicity and the rapidity of its administration, the lack of monitoring required, and the decreased bleeding/oozing tendency from the vascular access sites. The time spent for anticoagulation during a hemodialysis session was reported as 5 min with standard heparin (if no ACTESTER monitoring), 25–30 min with standard heparin (if ACTESTER monitoring required), and 1 min with tinzaparin. The cost analysis revealed that although tinzaparin is more than six times more expensive than standard heparin, the use of tinzaparin becomes similar to the use of standard heparin (USD 7.33 vs. USD 7.62 Canadian dollars for one hemodialysis session) if ACTESTER monitoring is performed (assuming that 22% of the sessions are routinely monitored and that one ACTESTER device is necessary for 8–10 dialysis stations, as applied in our unit). Conclusion: Our experience with tinzaparin was positive: it represents a simple and easy way to offer anticoagulation during maintenance hemodialysis, it seems associated with less postdialysis bleeding, it saves precious nursing time and is widely appreciated by patients and staff.

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          Most cited references 3

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          A comparison of subcutaneous low-molecular-weight heparin with warfarin sodium for prophylaxis against deep-vein thrombosis after hip or knee implantation.

          Deep-vein thrombosis is a potentially life-threatening complication of total hip or knee replacement. There are few data on the effectiveness and safety of warfarin as compared with low-molecular-weight heparin as prophylaxis against this problem. We therefore performed a randomized, double-blind trial in 1436 patients to evaluate the effectiveness and safety of low-molecular-weight heparin (given subcutaneously once daily) as compared with adjusted-dose warfarin to prevent venous thrombosis after hip or knee replacement. Treatment with the drugs was started postoperatively. The primary end point was deep-vein thrombosis as detected by contrast venography (performed a mean of 9.4 days after surgery in each group). Among the 1207 patients with interpretable venograms, 231 of 617 patients (37.4 percent) in the warfarin group and 185 of 590 patients (31.4 percent) in the low-molecular-weight-heparin group had deep-vein thrombosis (P = 0.03). The reduction in risk with low-molecular-weight heparin as compared with warfarin was 16 percent, and the absolute difference in the incidence of venous thrombosis was 6 percent in favor of low-molecular-weight heparin (95 percent confidence interval, 0.8 to 11.4 percent). The incidence of major bleeding was 1.2 percent (9 of 721 patients) in the warfarin group and 2.8 percent (20 of 715 patients) in the low-molecular-weight-heparin group (P = 0.04), and the absolute difference was 1.5 percent in favor of warfarin (95 percent confidence interval, 0.1 to 3.0 percent). Our data demonstrate that the small reduction in the incidence of venous thrombosis with low-molecular-weight heparin, as compared with warfarin, was offset by an increase in bleeding complications. Although the use of low-molecular-weight heparin is simpler, because it is administered subcutaneously without the need for monitoring, it may be more costly than warfarin. Warfarin is inexpensive, but the overall cost of its use is increased by the need to monitor the intensity of anticoagulation. At this time it is unclear which of these approaches is the most cost effective.
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            Indwelling urinary catheters in the elderly. Relation of "catheter life" to formation of encrustations in patients with and without blocked catheters.

            In order to define the natural history of indwelling urinary catheters in the elderly, 50 patients aged 65 years or older were followed. Their catheters had been in place for a mean of 33.2 days. When removed, 40.4 percent were blocked or showed poor flow. After the catheters were changed, the 14-day "catheter life" was 78 percent. About half the population had blocked catheters. They had a 14-day "catheter life" of only 31.8 percent (p = less than 0.01). Patients with blocked catheters ("blockers") excreted more alkaline urine, calcium, protein, and mucin than patients without blocked catheters ("nonblockers"), but urea-splitting bacteria were no more frequent. The mortality was not significantly different. Flow of water through catheters was closely related to extent of encrustations. Encrustations formed uniformly throughout the catheter lumen except when the tip was obstructed. The distribution and number of species of microorganisms (three and a half per specimen) were virtually identical in catheter and bladder urine, but the counts in the catheter urine were more frequently greater than 100,000 cfu/ml (p = less than 0.01). Patients with blocked catheters appear to be metabolically different from patients without blocked catheters and should have their catheters changed at seven to 10 days to avoid obstruction.
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              Dose titration study of tinzaparin, a low molecular weight heparin, in patients on chronic hemodialysis.

              The minimal necessary dose of Innohep (IH) (MNDI) (Innohep [tinzaparin], Leo Pharmaceutical Corp., Ballerup, Denmark) was examined in 40 patients switched from conventional heparin ([CH], Leo Pharmaceutical Corp.) to IH and in 13 patients already treated with IH. Clotting in the venous chamber and in the dialyzer was evaluated on a 4 point scale by visual inspection. IH was administrated as a bolus injection into the arterial side of the dialyzer at the beginning of dialysis sessions. The initial dose of IH was 50% of the total dose of CH used before the study (in respective IU). According to clotting in the venous chamber or dialyzer, the dose of IH was titrated by stepwise changes of 500 IU to the lowest possible dose until 3 subsequent dialysis sessions without clotting were obtained. The total dose of CH (bolus and infusion) before switching was 6,162 +/- 2,100 IU. The bleeding time from the cannulation site after dialysis, in 24 patients with A-V fistulas, was 7.1 +/- 2.8 min(triplicates). Eight patients were excluded before achieving the MNDI, 3 due to bleeding not clearly related to heparinization (1 due to gingival bleeding, 1 to epistaxis, and 1 to sugillations), 1 due to alopecia, 2 due to a need of more than 10,000 IU of IH, and 2 patients due to cessation of treatment resulting from anxiety. After switching over, the MNDI amounted to 66 +/- 26% in respective IU. The conversion IH/CH ratio correlated significantly to the blood flow rate and the type of dialyzer. When compared on 3 subsequent sessions before and after switching to IH, no differences were found in the bleeding time after decannulation and in clotting in the venous chamber while dialyzer clotting fell on the visual scale from an average of 0.36 to 0.19 (p < 0.01). No total clot formation was observed during the study. The MNDI correlated positively to the body weight, blood flow rate, and time on dialysis (with the respective coefficients of correlation of r being 0.58, 0.44, and 0.30, p < 0.05) and was also influenced by the type of dialyzer. The average MNDIs for the Hemoflow-FS hollow-fiber (Fresenius, Bad Homburg, Germany), Lundia PRO plate (Gambro, Lund, Sweden), and Polyflux hollow fiber (Gambro) were 2,571, 3,727, and 5,020 IU (p < 0.01, ANOVA). In patients on chronic hemodialysis, IH given as a bolus of 4,250 IU effectively prevented extracorporeal clotting during dialysis, similarly to CH. However, a considerable individual variation in MNDIs not related to the need for CH was observed, and this necessitates individual dosage adjustments to obtain the optimal prevention of clotting with minimal bleeding risk.
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                Author and article information

                Journal
                AJN
                Am J Nephrol
                10.1159/issn.0250-8095
                American Journal of Nephrology
                S. Karger AG
                0250-8095
                1421-9670
                2002
                February 2002
                28 March 2002
                : 22
                : 1
                : 58-66
                Affiliations
                Hemodialysis Unit, aNephrology Division, and bHematology Division, Maisonneuve-Rosemont Hospital, and cBiostatistics Department, University of Montreal, Canada
                Article
                46675 Am J Nephrol 2002;22:58–66
                10.1159/000046675
                11919404
                © 2002 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: 5, References: 18, Pages: 9
                Product
                Self URI (application/pdf): https://www.karger.com/Article/Pdf/46675
                Categories
                Clinical Study

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